Active Lubrication of Penetrating Devices

ABSTRACT

Penetrating systems and devices are described herein which include a penetrating portion having a fluid reservoir portion formed from two concentric hollow cylinders joined at one end with a substantially ring-shaped first end piece and associated at the other end with a substantially ring-shaped second end piece, the outer hollow cylinder including a plurality of pores in fluid communication with the fluid reservoir portion, the inner hollow cylinder defining a lumen in fluid communication with a second fluid reservoir portion, and the substantially ring-shaped second end piece forming a deformable barrier.

If an Application Data Sheet (ADS) has been filed on the filing date ofthis application, it is incorporated by reference herein. Anyapplications claimed on the ADS for priority under 35 U.S.C. §§119, 120,121, or 365(c), and any and all parent, grandparent, great-grandparent,etc. applications of such applications, are also incorporated byreference, including any priority claims made in those applications andany material incorporated by reference, to the extent such subjectmatter is not inconsistent herewith.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of the earliest availableeffective filing date(s) from the following listed application(s) (the“Priority Applications”), if any, listed below (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC §119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Priority Application(s)).

PRIORITY APPLICATIONS

None

If the listings of applications provided above are inconsistent with thelistings provided via an ADS, it is the intent of the Applicant to claimpriority to each application that appears in the DomesticBenefit/National Stage Information section of the ADS and to eachapplication that appears in the Priority Applications section of thisapplication.

All subject matter of the Priority Applications and of any and allapplications related to the Priority Applications by priority claims(directly or indirectly), including any priority claims made and subjectmatter incorporated by reference therein as of the filing date of theinstant application, is incorporated herein by reference to the extentsuch subject matter is not inconsistent herewith.

SUMMARY

In an aspect, a penetrating device includes, but is not limited to, afirst hollow cylinder having a first end and a second end, the firsthollow cylinder including a plurality of pores; a second hollow cylinderhaving a first end and a second end, the second hollow cylinder disposedwithin the first hollow cylinder and substantially coaxial to the firsthollow cylinder; a substantially ring-shaped end piece have an outeredge and an inner edge, the outer edge of the substantially ring-shapedend piece secured to the first end of the first hollow cylinder and theinner edge of the of the substantially ring-shaped end piece secured tothe first end of the second hollow cylinder, wherein the first hollowcylinder, the second hollow cylinder, and the substantially ring-shapedend piece form a penetrating edge; an internal fluid conduit defined bya space between the first hollow cylinder and the substantially coaxialsecond hollow cylinder, the internal fluid conduit in fluidcommunication with the plurality of pores along the length of the firsthollow cylinder; a connector portion with a first end and a second end,the connector portion disposed over and coaxial to a region of thesecond hollow cylinder proximal to the second end of the second hollowcylinder, the first end of the connector portion attached proximal tothe second end of the first hollow cylinder, the connector portion influid communication with the internal fluid conduit; a lumen defined bythe second hollow cylinder, the lumen having a first end and a secondend, the first end of the lumen in fluid communication with thepenetrating edge; a first fluid reservoir portion for holding a firstfluid composition, the first fluid reservoir portion associated with thesecond end of the connector portion, the first fluid reservoir portionin fluid communication with the connector portion and the internal fluidconduit; a second fluid reservoir portion, the second fluid reservoirportion associated with the second end of the second hollow cylinder,the second fluid reservoir portion in fluid communication with the lumendefined by the second hollow cylinder; a first initiator configured toinduce flow of the first fluid composition from the first fluidreservoir portion, through the internal fluid conduit, and out at leastone of the plurality of pores; and a second initiator configured toinduce flow into or out of the second fluid reservoir portion, throughthe lumen defined by the second hollow cylinder. In addition to theforegoing, other device aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In an aspect, a penetrating system includes, but is not limited to, apenetrating device and a computing device, the penetrating deviceincluding a first hollow cylinder having a first end and a second end,the first hollow cylinder including a plurality of pores; a secondhollow cylinder having a first end and a second end, the second hollowcylinder disposed within the first hollow cylinder and substantiallycoaxial to the first hollow cylinder; a substantially ring-shaped endpiece have an outer edge and an inner edge, the outer edge of thesubstantially ring-shaped end piece secured to the first end of thefirst hollow cylinder and the inner edge of the of the substantiallyring-shaped end piece secured to the first end of the second hollowcylinder, wherein the first hollow cylinder, the second hollow cylinder,and the substantially ring-shaped end piece form a penetrating edge; aninternal fluid conduit defined by a space between the first hollowcylinder and the substantially coaxial second hollow cylinder, theinternal fluid conduit in fluid communication with the plurality ofpores along the length of the first hollow cylinder; a connector portionwith a first end and a second end, the connector portion disposed overand coaxial to a region of the second hollow cylinder proximal to thesecond end of the second hollow cylinder, the first end of the connectorportion attached proximal to the second end of the first hollowcylinder, the connector portion in fluid communication with the internalfluid conduit; a lumen defined by the second hollow cylinder, the lumenhaving a first end and a second end, the first end of the lumen in fluidcommunication with the penetrating edge; a first fluid reservoir portionfor holding a first fluid composition, the first fluid reservoir portionassociated with the second end of the connector portion, the first fluidreservoir portion in fluid communication with the connector portion andthe internal fluid conduit; a second fluid reservoir portion, the secondfluid reservoir portion associated with the second end of the secondhollow cylinder, the second fluid reservoir portion in fluidcommunication with the lumen defined by the second hollow cylinder; afirst initiator configured to induce flow of the first fluid compositionfrom the first fluid reservoir portion, through the internal fluidconduit, and out at least one of the plurality of pores; and a secondinitiator configured to induce flow into or out of the second fluidreservoir portion, through the lumen defined by the second hollowcylinder; and a computing device including a processor and operablycoupled to the penetrating device, the computing device includingcircuitry configured to controllably actuate at least one of the firstinitiator to the second initiator. In addition to the foregoing, othersystem aspects are described in the claims, drawings, and text forming apart of the present disclosure.

In an aspect, a penetrating device includes, but is not limited to afirst hollow cylinder having a first end and a second end, the firsthollow cylinder including a plurality of pores, the second end of thefirst hollow cylinder having a connector portion; a second hollowcylinder having a first end and a second end, the second hollow cylinderdisposed within the first hollow cylinder and substantially coaxial tothe first hollow cylinder; a substantially ring-shaped first end piecehaving an outer edge and an inner edge, the outer edge of thesubstantially ring-shaped first end piece secured to the first end ofthe first hollow cylinder and the inner edge of the substantiallyring-shaped first end piece secured to the first end of the secondhollow cylinder, wherein the first hollow cylinder, the second hollowcylinder, and the substantially ring-shaped first end piece form apenetrating edge; a substantially ring-shaped second end piece having anouter edge and an inner edge, the outer edge of the substantiallyring-shaped second end piece adjacent to a portion of the first hollowcylinder proximal to the second end of the first hollow cylinder and theinner edge of the substantially ring-shaped second end piece adjacent toa portion of the second hollow cylinder proximal to the second end ofthe second hollow cylinder, the substantially ring-shaped second endpiece forming a deformable barrier; a fluid reservoir portion forholding a fluid composition, the fluid reservoir portion defined by thefirst hollow cylinder, the second hollow cylinder, the substantiallyring-shaped first end piece, and the substantially ring-shaped secondend piece, the fluid reservoir portion in fluid communication with theplurality of pores; and a lumen defined by the second hollow cylinder,the lumen having a first end and a second end, the first end of thelumen in fluid communication with the penetrating edge. In addition tothe foregoing, other aspects of a device are described in the claims,drawings, and text forming a part of the present disclosure.

In an aspect, a penetrating system includes, but is not limited to, apenetrating device including a first hollow cylinder having a first endand a second end, the first hollow cylinder including a plurality ofpores, the second end of the first hollow cylinder having a connectorportion; a second hollow cylinder having a first end and a second end,the second hollow cylinder disposed within the first hollow cylinder andsubstantially coaxial to the first hollow cylinder; a substantiallyring-shaped first end piece having an outer edge and an inner edge, theouter edge of the substantially ring-shaped first end piece secured tothe first end of the first hollow cylinder and the inner edge of thesubstantially ring-shaped first end piece secured to the first end ofthe second hollow cylinder, wherein the first hollow cylinder, thesecond hollow cylinder, and the substantially ring-shaped first endpiece form a penetrating edge; a substantially ring-shaped second endpiece having an outer edge and an inner edge, the outer edge of thesubstantially ring-shaped second end piece adjacent to a portion of thefirst hollow cylinder proximal to the second end of the first hollowcylinder and the inner edge of the substantially ring-shaped second endpiece adjacent to a portion of the second hollow cylinder proximal tothe second end of the second hollow cylinder, the substantiallyring-shaped second end piece forming a deformable barrier; a first fluidreservoir portion for holding a first fluid composition, the first fluidreservoir portion defined by the first hollow cylinder, the secondhollow cylinder, the substantially ring-shaped first end piece, and thesubstantially ring-shaped second end piece, the first fluid reservoirportion in fluid communication with the plurality of pores; and a lumendefined by the second hollow cylinder, the lumen having a first end anda second end, the first end of the lumen in fluid communication with thepenetrating edge; and a second fluid reservoir portion for holding asecond fluid composition, the second fluid reservoir portion includingan initiator, the second fluid reservoir portion attached to thepenetrating device through the connector portion of the first hollowcylinder, the second fluid reservoir portion in fluid communication withthe second end of the lumen defined by the second hollow cylinder. Inaddition to the foregoing, other aspects of a system are described inthe claims, drawings, and text forming a part of the present disclosure.

In an aspect, a penetrating device includes, but is not limited to, afirst hollow cylinder having a first end and a second end, the firsthollow cylinder including a plurality of pores; a second hollow cylinderhaving a first end and a second end, the second hollow cylinder disposedwithin the first hollow cylinder and substantially coaxial to the firsthollow cylinder, the second end of the second hollow cylinder having aconnector portion; a substantially ring-shaped end piece having an outeredge and an inner edge, the outer edge of the substantially ring-shapedend piece secured to the first end of the first hollow cylinder and theinner edge of the substantially ring-shaped end piece secured to thefirst end of the second hollow cylinder, wherein the first hollowcylinder, the second hollow cylinder, and the substantially ring-shapedend piece form a penetrating edge; an internal fluid conduit defined bya space between the first hollow cylinder and the substantially coaxialsecond hollow cylinder, the internal fluid conduit in fluidcommunication with the plurality of pores along the length of the firsthollow cylinder; a fluid reservoir portion for holding a fluidcomposition, the fluid reservoir portion including a hollow structurewith a first end and a second end, the hollow structure disposed overand substantially coaxial to a region of the second hollow cylinderproximal to the second end of the second hollow cylinder, the first endof the hollow structure secured to the second end of the first hollowcylinder and the second end of the hollow structure secured proximal tothe second end of the second hollow cylinder, the hollow structure influid communication with the internal fluid conduit; and a lumen definedby the second hollow cylinder, the lumen having a first end and a secondend, the first end of the lumen in fluid communication with thepenetrating edge. In addition to the foregoing, other aspects of adevice are described in the claims, drawings, and text forming a part ofthe present disclosure.

In an aspect, a penetrating system includes, but is not limited to, apenetrating device including a first hollow cylinder having a first endand a second end, the first hollow cylinder including a plurality ofpores; a second hollow cylinder having a first end and a second end, thesecond hollow cylinder disposed within the first hollow cylinder andsubstantially coaxial to the first hollow cylinder, the second end ofthe second hollow cylinder having a connector portion; a substantiallyring-shaped end piece having an outer edge and an inner edge, the outeredge of the substantially ring-shaped end piece secured to the first endof the first hollow cylinder and the inner edge of the substantiallyring-shaped end piece secured to the first end of the second hollowcylinder, wherein the first hollow cylinder, the second hollow cylinder,and the substantially ring-shaped end piece form a penetrating edge; aninternal fluid conduit defined by a space between the first hollowcylinder and the substantially coaxial second hollow cylinder, theinternal fluid conduit in fluid communication with the plurality ofpores along the length of the first hollow cylinder; a first fluidreservoir portion for holding a first fluid composition, the first fluidreservoir portion including a hollow structure with a first end and asecond end, the hollow structure disposed over and substantially coaxialto a region of the second hollow cylinder proximal to the second end ofthe second hollow cylinder, the first end of the hollow structuresecured to the second end of the first hollow cylinder and the secondend of the hollow structure secured proximal to the second end of thesecond hollow cylinder, the hollow structure in fluid communication withthe internal fluid conduit;

and a lumen defined by the second hollow cylinder, the lumen having afirst end and a second end, the first end of the lumen in fluidcommunication with the penetrating edge; and a second fluid reservoirportion including an initiator, the second fluid reservoir portionattached to the penetrating device through the connector portion of thesecond hollow cylinder, the second fluid reservoir portion in fluidcommunication with the second end of the lumen defined by the secondhollow cylinder. In addition to the foregoing, other aspects of a systemare described in the claims, drawings, and text forming a part of thepresent disclosure.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows a schematic of a penetrating device.

FIG. 2A shows a schematic of an external view of a penetrating device.

FIG. 2B shows a schematic of a longitudinal cross-section through apenetrating device.

FIG. 3 shows a schematic of longitudinal and transverse cross-sectionsthrough a penetrating device.

FIG. 4 shows a schematic of a longitudinal cross-section through apenetrating device.

FIG. 5A shows a schematic of an external view of a penetrating devicewith parallel fluid reservoirs.

FIG. 5B shows a schematic of a longitudinal cross-section through apenetrating device with parallel fluid reservoirs.

FIG. 6A shows a schematic of an external view of a penetrating deviceconnected to a first and second fluid reservoir portion through a flowconduit.

FIG. 6B shows a schematic of a longitudinal cross-section through apenetrating device connected to a first and second fluid reservoirportion through a flow conduit.

FIG. 7A shows a schematic of an initiator of a penetrating device.

FIG. 7B shows a schematic of an initiator of a penetrating device.

FIG. 8 shows a schematic of a penetrating device including a computingcomponent and at least one sensor.

FIG. 9 shows a schematic of a penetrating system having a penetratingdevice and a computing device.

FIG. 10 shows further aspects of a penetrating system such as shown inFIG. 9.

FIG. 11 shows a schematic of a penetrating system including a first andsecond pump.

FIG. 12 shows further aspects of a penetrating system such as shown inFIG. 9.

FIG. 13A shows a schematic of a longitudinal cross-section through apenetrating device including a needle actuation mechanism in a retractedstate.

FIG. 13B shows a schematic of a longitudinal cross-section through apenetrating device including a needle actuation mechanism in a deployedstate.

FIG. 14A shows a schematic of an external view a penetrating device.

FIG. 14B shows a schematic of a longitudinal cross-section through apenetrating device.

FIG. 15A shows a schematic of a longitudinal cross-section through apenetrating device including a deformable substantially ring-shapedsecond end piece.

FIG. 15B shows a schematic of a longitudinal cross-section through apenetrating device including a deformable substantially ring-shapedsecond end piece.

FIG. 16A shows a schematic of a longitudinal cross-section through apenetrating device including a moveable substantially ring-shaped secondend piece.

FIG. 16B shows a schematic of a longitudinal cross-section through apenetrating device including a moveable substantially ring-shaped secondend piece.

FIG. 17A shows a schematic of a penetrating system.

FIG. 17B shows a schematic of a penetrating system.

FIG. 18A shows a schematic of an external view of a penetrating system.

FIG. 18B shows a schematic of a longitudinal cross-section through apenetrating system.

FIG. 19A shows a schematic of a longitudinal cross-section through apenetrating system including a deformable substantially ring-shapedsecond end piece.

FIG. 19B shows a schematic of a longitudinal cross-section through apenetrating system including a deformable substantially ring-shapedsecond end piece.

FIG. 20A shows a schematic of a longitudinal cross-section through apenetrating system including a moveable substantially ring-shaped secondend piece.

FIG. 20B shows a schematic of a longitudinal cross-section through apenetrating system including a moveable substantially ring-shaped secondend piece.

FIG. 21 shows a schematic of a penetrating system including a secondfluid reservoir portion attached to a penetrating device through a flowconduit.

FIG. 22 shows a schematic of a penetrating system including a secondfluid reservoir portion and a pump attached a penetrating device througha flow conduit.

FIG. 23 shows a schematic of a penetrating system including a computingcomponent.

FIG. 24 shows a schematic of a penetrating system including a computingdevice, a pump, and a second fluid reservoir portion attached to apenetrating device through a flow conduit.

FIG. 25A shows a schematic of an external view of a penetrating device.

FIG. 25B shows a schematic of a longitudinal cross-section through apenetrating device.

FIG. 26A shows a schematic of an external view of a penetrating deviceand a flow pattern of a fluid composition in response to an appliedpressure.

FIG. 26B shows a schematic of a longitudinal cross-section through apenetrating device and a flow pattern of a fluid composition in responseto an applied pressure.

FIG. 27A shows a schematic of a penetrating system.

FIG. 27B shows a schematic of a penetrating system.

FIG. 28A shows a schematic of an external view of a penetrating system.

FIG. 28B shows a schematic of a longitudinal cross-section through apenetrating system.

FIG. 29A shows a schematic of an external view of a penetrating systemand a flow pattern of a fluid composition in response to an appliedpressure.

FIG. 29B shows a schematic of a longitudinal cross-section through apenetrating system and a flow pattern of a fluid composition in responseto an applied pressure.

FIG. 30 shows a schematic of a penetrating system including a secondfluid reservoir portion attached to a penetrating device through a flowconduit.

FIG. 31 shows a schematic of a penetrating system including a secondfluid reservoir portion and a pump attached to a penetrating devicethrough a flow conduit.

FIG. 32 shows a schematic of a penetrating system including a computingcomponent.

FIG. 33 shows a schematic of a penetrating system including a computingdevice and a pump.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

In general, penetration of a medium by a penetrating device, e.g., aneedle, must overcome friction, which can damage the medium or thedevice and cause an increase in time spent during penetration. Inparticular, mammalian tissue penetration by a penetrating device, e.g.,a hypodermic needle, can induce pain during the injection process, bothfrom the initial piercing of the tissue and the sliding friction of theneedle surface against the tissue. See, e.g., Gill & Prausnitz (2007) J.Diabetes Sci. Technol. 1:725-729, which is incorporated herein byreference. In addition, the tissue injection process is associated withan increased risk of infection at the injection site. See, e.g., Hutinet al. (2003) Bulletin of the World Health Organization 81(7), which isincorporated herein by reference. Described herein are penetratingsystems and devices, the systems and devices including a plurality ofpores distributed along the length of a penetrating portion of thesystems and devices, the plurality of pores in fluid communication witha fluid reservoir, the fluid reservoir configured to hold a fluidcomposition, wherein the fluid composition flows laterally out of theplurality of pores to aide in the injection process.

With reference to FIG. 1, shown is an example of a penetrating device.Penetrating device 100 includes penetrating portion 110 and a reservoirportion 120. Penetrating portion 110 includes penetrating edge 130,connector portion 140, and a plurality of pores 150. Reservoir portion120 is attached to penetrating portion 110 through connector portion140. Reservoir portion 120 includes a first fluid reservoir portion forholding a first fluid composition and a second fluid reservoir portion.Reservoir portion 120 further includes first initiator 160 and secondinitiator 170. First initiator 160 is configured to induce flow of thefirst fluid composition from the first fluid reservoir portion throughan internal fluid conduit of penetrating portion 110, and out at leastone of the plurality of pores 150. Second initiator 170 is configured toinduce flow into or out of the second fluid reservoir portion through acentral lumen and out penetrating edge 130.

FIGS. 2A and 2B illustrate further aspects of a penetrating device suchas shown in FIG. 1. FIG. 2A shows a schematic of an exterior view ofpenetrating device 100. Penetrating device 100 includes penetratingportion 110 and reservoir portion 120. Penetrating portion 110 includespenetrating edge 130, connector portion 140, and plurality of pores 150.Penetrating portion 110 is connected to reservoir portion 120 throughconnector portion 140. Reservoir portion 120 includes first initiator160 and second initiator 170.

FIG. 2B shows a schematic of a longitudinal cross-section throughpenetrating device 100. Penetrating device 100 includes a first hollowcylinder 200 having a first end 202 and a second end 204, the firsthollow cylinder 200 including plurality of pores 150. Penetrating device100 further includes a second hollow cylinder 206 having a first end 208and a second end 210, the second hollow cylinder 206 is disposed withinthe first hollow cylinder 200 and substantially coaxial to the firsthollow cylinder 200. Penetrating device 100 further includes asubstantially ring-shaped end piece 212 having an outer edge 214 and aninner edge 216, the outer edge 214 of the substantially ring-shaped endpiece 212 secured to the first end 202 of the first hollow cylinder 200and the inner edge 216 of the substantially ring-shaped end piece 212secured to the first end 208 of the second hollow cylinder 206, whereinthe first hollow cylinder 200, the second hollow cylinder 206, and thesubstantially ring-shaped end piece 212 form a penetrating edge 130.Penetrating device 100 further includes internal fluid conduit 218defined by a space between the first hollow cylinder 200 and thesubstantially coaxial second hollow cylinder 206, the internal fluidconduit 218 in fluid communication with the plurality of pores 150 alongthe length of first hollow cylinder 200. Penetrating device 100 includesa connector portion 140 with a first end 220 and a second end 222, theconnector portion 140 disposed over and coaxial to a region 224 ofsecond hollow cylinder 206 proximal to the second end 210 of the secondhollow cylinder 206, the first end 220 of the connector portion 140attached proximal to the second end 204 of the first hollow cylinder200, the connector portion 140 in fluid communication with the internalfluid conduit 218. Penetrating device 100 further includes a lumen 226defined by the second hollow cylinder 206, the lumen 226 having a firstend 228 and a second end 230, the first end 228 of the lumen 226 influid communication with the penetrating edge 130. Reservoir portion 120of penetrating device 100 includes first fluid reservoir portion 232 forholding a first fluid composition, the first fluid reservoir portion 232associated with the second end 222 of the connector portion 140, thefirst fluid reservoir portion in fluid communication with the connectorportion 140 and the internal fluid conduit 218. Reservoir portion 120 ofpenetrating device 100 includes second fluid reservoir portion 234, thesecond fluid reservoir portion 234 associated with the second end 210 ofthe second hollow cylinder 206, the second fluid reservoir portion 234in fluid communication with the lumen 226 defined by the second hollowcylinder 206. Penetrating device 100 includes a first initiator 160configured to induce flow of the first fluid composition from the firstfluid reservoir portion 232, through the internal fluid conduit 218, andout at least one of the plurality of pores 150. Penetrating device 100includes a second initiator 170 configured to induce flow into or out ofthe second fluid reservoir portion 234, through the lumen 226 defined bythe second hollow cylinder 206.

FIG. 3 illustrates further aspects of penetrating device 100. Shown arecross-sections 310, 320, 330, 340, and 350 through the central axis 300of penetrating device 100. Cross-section 310 shows a diagonalcross-sectional view through first hollow cylinder 200, second hollowcylinder 206, and substantially ring-shaped end piece 212. The outeredge of substantially ring-shaped end piece 212 is secured to firsthollow cylinder 200 and the inner edge of substantially ring-shaped endpiece 212 is secured to second hollow cylinder 206. The central portionof cross-section 310 includes lumen 226 defined by second hollowcylinder 206. Cross-section 320 shows a transverse cross-sectional viewthrough first hollow cylinder 200 and second hollow cylinder 206. Firsthollow cylinder 200 further includes a plurality of pores 150. Alsoshown is internal fluid conduit 218 defined by a space between firsthollow cylinder 200 and second hollow cylinder 206. In an aspect, thespace between the first hollow cylinder and the second hollow cylinderis not contiguous. For example, the first hollow cylinder and the secondhollow cylinder may be connected through one or more struts. The centralportion of cross-section 320 includes lumen 226 defined by second hollowcylinder 206. Cross-section 330 shows a transverse cross-sectional viewthrough connector portion 140 and second hollow cylinder 206. Connectorportion 140 is shown disposed coaxial to second hollow cylinder 206.Connector portion 140 and second hollow cylinder 206 define a space influid communication with the internal fluid conduit. The central portionof cross-section 330 includes lumen 226 defined by second hollowcylinder 206. Cross-section 340 shows a transverse cross-sectional viewthrough first initiator 160 and second initiator 170. In an aspect,first initiator 160 and second initiator 170 each include a plunger,e.g., a syringe plunger. Cross-section 340 includes first fluidreservoir portion 232 and second fluid reservoir portion 234. In anaspect, second fluid reservoir portion 234 is disposed within the firstfluid reservoir portion 232 and substantially coaxial to the first fluidreservoir portion 232. First initiator 160 is disposed in first fluidreservoir portion 232 and second initiator 170 is disposed in secondfluid reservoir portion 234. Cross-section 350 shows a transversecross-sectional view through another portion of first initiator 160 andsecond initiator 170. In an aspect, a portion of second initiator 170 isdisposed within first initiator 160 and substantially coaxial to firstinitiator 160.

FIG. 4 illustrates further aspects of penetrating device 100. FIG. 4shows a schematic of fluid flow in response to actuation of firstinitiator 160 and second initiator 170 of penetrating device 100. Shownis actuation of first initiator 160 with downward pressure 400 intofirst fluid reservoir portion 232, inducing flow of the first fluidcomposition from first fluid reservoir portion 232, through connectorportion 140, into internal flow conduit 218, and out at least one of theplurality of pores 150 along the length of first hollow cylinder 200.Also shown is actuation of second initiator 170 with downward pressure410 into second fluid reservoir portion 234, inducing flow from secondfluid reservoir portion 234, through lumen 226 defined by second hollowcylinder 206, and out penetrating edge 130. In an aspect, the firstfluid composition flows out laterally along the length of thepenetrating portion while the second fluid composition flows out the endof the penetrating portion.

In an aspect, first initiator 160 is actuated with downward pressure toinduce flow of the first fluid composition from the first fluidreservoir portion, through the connector portion, into the internal flowconduit, and out at least one of the plurality of pores while secondinitiator 170 is actuated with upward pressure to induce flow of asecond fluid composition through the lumen and into the second fluidreservoir portion. For example, the second initiator can be actuatedwith upward pressure to draw a fluid composition into the second fluidreservoir portion. For example, the second initiator can be actuatedwith upward pressure to aspirate a captured sample, e.g., blood, tissue,marrow, or cerebral spinal fluid, into the lumen defined by the secondhollow cylinder and into the second fluid reservoir portion.

Penetrating device 100 includes first hollow cylinder 200. In an aspect,the diameter of the first hollow cylinder is dependent upon the materialbeing penetrated, e.g., pierced, by the penetrating device. In anaspect, the diameter of the first hollow cylinder is sized for use inadministering to an animal, e.g., a mammalian subject, an injectableagent, e.g., a vaccine or therapeutic agent, into a tissue of theanimal. In an aspect, the diameter of the first hollow cylinder is sizedfor use in removing from an animal a bodily tissue, e.g., blood or otheraspirate, or solid or semi-solid material. In an aspect, the diameter ofthe first hollow cylinder is sized for use in both delivering andremoving fluid from an animal a bodily tissue, e.g., as in a washaspirate. In an aspect, the cross-sectional diameter of the first hollowcylinder is about 5 millimeters to about 0.1 millimeters. For exampleand without limitation, the cross-section diameter of the first hollowcylinder can be 5 millimeters, 4.8 millimeters, 4.6 millimeters, 4.4millimeters, 4.2 millimeters, 4.0 millimeters, 3.8 millimeters, 3.6millimeters, 3.4 millimeters, 3.2 millimeters, 3.0 millimeters, 2.8millimeters, 2.6 millimeters, 2.4 millimeters, 2.2 millimeters, 2.0millimeters, 1.8 millimeters, 1.6 millimeters, 1.4 millimeters, 1.2millimeters, 1.0 millimeters, 0.9 millimeters, 0.8 millimeters, 0.7millimeters, 0.6 millimeters, 0.5 millimeters, 0.4 millimeters, 0.3millimeters, 0.2 millimeters, or 0.1 millimeters.

In an aspect, the cross-sectional diameter of the first hollow cylinderis sized for agricultural use. For example, the first hollow cylindercan be sized for piercing a plant (e.g., a tree, shrub, flowering plant,food plant, etc.). For example, the first hollow cylinder can be sizedfor piercing a tissue (e.g, a stem or root) of a plant. For example, thefirst hollow cylinder can be sized for piercing a plant bed, plantcontainer, or planted soil. In an aspect, the diameter of the firsthollow cylinder is sized for use in agriculture for administering asubstance to a plant or its environs. In an aspect, the diameter of thefirst hollow cylinder is sized for use in agriculture for removing asubstance from a plant (e.g., tapping) or its environs. For example andwithout limitation, the cross-sectional diameter of the first hollowcylinder is about 0.1 centimeters to about 10 centimeters.

In an aspect, the cross-sectional diameter of the first hollow cylinderis sized for industrial use. For example, the first hollow cylinder canbe sized for piercing metal, wood, concrete, plastic, polymer,fiberglass, resin, acrylic, latex, rubber, paper, or fabric. In anaspect, the diameter of the first hollow cylinder is sized for use inmanufacturing (e.g., in dispensing). For example and without limitation,the cross-sectional diameter of the first hollow cylinder is about 0.5centimeters to about 10 centimeters.

In an aspect, the length of the first hollow cylinder is dependent uponthe material being penetrated, e.g., pierced, by the penetrating device.In an aspect, the length of the penetrating portion of the penetratingdevice is dependent upon the length of the first hollow cylinder. In anaspect, the length of the first hollow cylinder is appropriately sizedfor piercing a tissue of an animal. In an aspect, the length of thefirst hollow cylinder is appropriately sized for piercing a tissue of amammalian subject. In an aspect, the length of the first hollow cylinderis comparable to the length of a standard hypodermic needle. In anaspect, the first hollow cylinder is about ½ inch to about 2 inch inlength. For example, the first hollow cylinder can be ½ inch, ⅝ inch, 1inch, 1½ inches, or 2 inches in length. In an aspect, the length of thefirst hollow cylinder is comparable to the length of a standard finebiopsy needle. In an aspect, the length of the first hollow cylinder iscomparable to the length of a standard bone-access device, e.g., a bonebiopsy or delivery device. In an aspect, the length of the first hollowcylinder is comparable to the length of a standard biopsy needle. In anaspect, the first hollow cylinder is about ½ inch to about 20 inches inlength. For example, the first hollow cylinder can be ½ inch, 1 inch, 1½inches, 2 inches, 2½ inches, 3 inches, 3½ inches, 4 inches, 4½ inches, 5inches, 5½ inches, 6 inches, 6½ inches, 7 inches, 7½ inches, 8 inches,8½ inches, 9 inches, 9½ inches, 10 inches, 10½ inches, 11 inches, 11½inches, 12 inches, 12½ inches, 13 inches, 13½ inches, 14 inches, 14½inches, 15 inches, 15½ inches, 16 inches, 16½ inches, 17 inches, 17½inches, 18 inches, 18½ inches, 19 inches, 19½ inches, or 20 inches inlength.

In an aspect, the length of the first hollow cylinder is sized foragricultural use. For example, the first hollow cylinder can be sizedfor piercing a tissue of a plant, such as a flowering plant or tree, orits environs. In an aspect, the cross-sectional diameter of the firsthollow cylinder is sized for industrial use. For example and withoutlimitation, the length of the first hollow cylinder is about ½ inch toabout 20 inches in length.

In an aspect, the first hollow cylinder is formed from stainless-steel.In an aspect, the first hollow cylinder is formed from type 304 or A2stainless-steel tubing including 18% chromium and 8% nickel. In anaspect, the first hollow cylinder is formed from 304L, 316, or 316Ltypes of steel. In an aspect, the first hollow cylinder is formed from astainless-steel tube through the process of tube drawing. For example,the first hollow cylinder can be formed from a stainless-steel tube bydrawing the tube through progressively smaller dies until an appropriateouter diameter is achieved. Non-limiting examples of tube drawingtechniques include tube sinking, mandrel drawing, stationary mandrel,moving mandrel, or floating mandrel, wherein a mandrel, e.g., a steelrod, is used to define the inner diameter of the stainless-steel tube asthe tube is drawn through the die.

In an aspect, the first hollow cylinder is formed from at least onemetal, alloy, plastic, glass, polymer, or ceramic. In an aspect, thefirst hollow cylinder is formed from at least one metal, e.g., iron,titanium, molybdenum, cobalt, chromium, zinc, magnesium, and nickel. Inan aspect, the first hollow cylinder is formed from an alloy, e.g.,iron-chromium-nickel alloys, cobalt-chromium alloys,cobalt-nickel-chromium-molybdenum alloys, nickel-titanium alloys, ormagnesium alloys.

In an aspect, the first hollow cylinder is formed from at least onematerial capable of being shaped, molded, or printed to form the firsthollow cylinder. Non-limiting examples of shapeable, moldable, orprintable materials includes acrylic, nylon, plastic, ceramic, resin,rubber, epoxy, thermoplastic, photopolymer, polyurethane, silicone, orlatex. In an aspect, the first hollow cylinder is formed from a polymer.In an aspect, the first hollow cylinder is formed from plastic. Forexample, the first hollow cylinder can be formed from at least one ofpolystyrene, polymethylmethacrylate, or nylon using micro injectionmolding. See, e.g., Kim & Colton (2005) J. Med. Eng. Technol.29:181-186, which is incorporated herein by reference. In an aspect, thefirst hollow cylinder is formed using one or more thermoplastic resins,non-limiting examples of which include polyether ether ketone (PEEK),polyetherimide (PEI), liquid crystal polymers (LCP), nylon,thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU). In anaspect, the first hollow cylinder is formed using glass filled nylons orcarbon filled LCP. Other non-limiting examples of injection moldingmaterials include acrylonitrile butadiene styrene (ABS), acetal, nylon,polyetherimide (PEI), polycarbonate, polylactic acid, polypropylene,polyvinyl chloride, and thermoplastic elastomers.

In an aspect, the first hollow cylinder is formed from a porousmaterial. In an aspect, the first hollow cylinder is formed from porousglass. For example, the first hollow cylinder can be formed from porousglass including nanometer and/or micrometer pores through metastablephase separation of borosilicate glasses, followed by liquid extractionof one of the formed phases, through a sol-gel process, or throughsintering of glass powder. In an aspect, the first hollow cylinder isformed from porous ceramic. For example, the first hollow cylinder canbe formed from aluminum oxide and/or silicon carbide.

In an aspect, the first hollow cylinder is manufactured from a porousmaterial formed by sintering thermoplastic powders. Non-limitingexamples of thermoplastic powders include polyethylene (PE),polypropylene (PP), polyvinylidene fluoride (PVDF),polytetrafluoroethylene (PTFE), PP-PE copolymers, and nylon.

In an aspect, the first hollow cylinder is formed from at least one ofsintered metal particulate, glass particulate, or ceramic particulate.For example, the first hollow cylinder can be formed using an additivemanufacturing process using a metal, glass, or ceramic particulate and alaser to sinter the particulate material into a solid structure definedby a 3D® model. For example, the first hollow cylinder can be formedusing selective laser melting to fully melt the particulate material. Inan aspect, the metal particulate includes a metal alloy. Non-limitingexamples of metal alloys include stainless steel, maraging steel, cobaltchromium, inconel (nickel-chromium alloys), and titanium alloys. In anaspect, the sintered ceramic particulate includes aluminum oxide,zirconium dioxide, or calcium hydroxylapatite.

In an aspect, the first hollow cylinder is formed using an additivemanufacturing process. Additive manufacturing refers to a class ofmanufacturing process in which a three-dimensional object is built byadding layers of material upon one another. Other terms include layeredmanufacturing, direct digital manufacturing, or solid freeformfabrication. Non-limiting examples of additive manufacturing processesinclude liquid-based processes, e.g., stereolithography, jettedphotopolymer, and ink jet printing; powder-based processes, e.g.,selective laser sintering, direct metal laser sintering, andthree-dimensional printing; and solid-based processes, e.g., laminatedobject manufacturing, fused deposition modeling. In an aspect, the firsthollow cylinder is formed using a subtractive manufacturing process.Subtractive manufacturing refers to a class of manufacturing process inwhich a three-dimensional object is built by cutting away material.Non-limiting examples of subtractive manufacturing processes includemachining, milling, turning, and drilling. Other non-limiting examplesof manufacturing processes include molding, e.g., blow molding,injection molding, or thermoforming; and casting, e.g., centrifugalcasting, die casting, sand casting, shell mold casting.

In an aspect, the first hollow cylinder is generated usingstereolithography using one or more optically curable photopolymers.Non-limiting examples of materials useful for stereolithography includepoly(ethylene glycol)1500, Accura 60, Accura 25, Accura Xtreme, Somos9420, Somos 11122, Somos 18420, Somos DMX, Rigi2200,TuskXC2700T/Tusk2700W, Nano5000, Flex45, Flex65, Flex70B, Flex 80,Protogen White. Other non-limiting examples of stereolithography includethree-dimensional printing (3D printing), optical fabrication,photo-solidification, solid free-form fabrication, and solid imaging.

In an aspect, the first hollow cylinder is generated by 3D printingusing an inkjet technology, e.g., PolyJet™ (from Objet Ltd) in whichphotopolymer materials are jetted in ultra-thin layers onto a build trayand cured layer by layer with UV light. Non-limiting examples ofmaterials for use in generating a wearable injection guide using inkjettechnology include Fullcure 720, VeroWhite, VeroBlack, VeroBlue, andVeroGray for rigid structures; Durus for semi-flexible structures; andTango Elastomers for rubber-like structures. Other examples of 3Dprinters include ProJet and ZPrinters available from 3D SystemsCorporation, Rock Hill S.C. and Freeform Pico, Asiga, Anaheim Hills,Calif.

In an aspect, the first hollow cylinder is generated using selectivelaser sintering in which a high power laser, e.g., a carbon dioxidelaser, is used to fuse small particles of plastic, metal, ceramic, glasspowders, or combinations thereof into a mass that has a desiredthree-dimensional shape. Non-limiting examples of material for use ingenerating a first hollow cylinder using laser sintering includepolyamide, nylon, carbon, hydroxyapatite, glass filled polyamide, andalumide.

In an aspect, the first hollow cylinder is generated using fuseddeposition modeling. Fused deposition modeling is an extrusion basedthree-dimensional modeling process using thermoplastic materials.Non-limiting examples of materials for use in fused deposition modelinginclude the thermoplastics ABS, ABS/F1, polycarbonate, and Ultem 9085.The uPrint SE from Stratasys (Eden Prairie, Minn.) or the DimensionElite 3D printer from Dimension, Inc. (Eden Prairie, Minn.) arenon-limiting examples of systems for fused deposition modeling withthermoplastics.

In an aspect, all or part of device 100 is manufactured using amanufacturing process in combination with computer-aided engineeringsoftware. For example, a three-dimensional rendering of all or part ofdevice 100 can be created using a computer-aided engineering softwarepractice, the three-dimensional rendering used as a template for microinjection molding with a thermoplastic resin. For example, astereolithography file including a three-dimensional rendering of all orpart of the device can be generated using a computer-aided design (CAD)program. Non-limiting examples of modeling software include MoldFlow®,Modex3D®, CADMOULD®, and SIGAMA®. See, e.g., Xie et al (2011) Modellingand Simulation for Injection Molding Process, in “Computational FluidDynamics Technology” ed. Igor Minin, InTech, ISBN 978-953-307-169-5,which is incorporated herein by reference.

The first hollow cylinder includes a plurality of pores. In an aspecteach of the plurality of pores is substantially perpendicular to acentral axis of the first hollow cylinder. In an aspect, each of theplurality of pores is oriented at 90 degrees relative to the centralaxis of the first hollow cylinder. In an aspect, each of the pluralityof pores is oriented at 45 degrees relative to the central axis of thefirst hollow cylinder. In an aspect, each of the plurality of pores isoriented at about 90 degrees to about 20 degrees relative to the centralaxis of the first hollow cylinder. For example, each of the plurality ofpores can be oriented at 90 degrees, 85 degrees, 80 degrees, 75 degrees,70 degrees, 65 degrees, 60 degrees, 55 degrees, 50 degrees, 45 degrees,40 degrees, 35 degrees, 30 degrees, 25 degrees, or 20 degrees relativeto the central axis of the first hollow cylinder. In an aspect, each ofthe plurality of pores is at substantially the same angle relative tothe central axis of the first hollow cylinder. For example, each of theplurality of pores can be machined at a substantially 90 degreesrelative to the central axis of the first hollow cylinder. In an aspect,one or more of the plurality of pores are at different angles relativeto the central axis of the first hollow cylinder. For example, a firsthollow cylinder manufactured from a porous material, e.g., porousceramic, may have pores angled at varied degrees relative to the centralaxis of the first hollow cylinder.

In an aspect, the plurality of pores includes at least two pores. In anaspect, the plurality of pores includes 2 pores to about 100 pores. Forexample, the plurality of pores can include 2 pores, 3 pores, 4 pores, 5pores, 6 pores, 7 pores, 8 pores, 9 pores, 10 pores, 15 pores, 20 pores,25 pores, 30 pores, 35 pores, 40 pores, 45 pores, 50 pores, 55 pores, 60pores, 65 pores, 70 pores, 75 pores, 80 pores, 85 pores, 90 pores, 95pores, or 100 pores. In an aspect, the plurality of pores includes about100 pores to about 100,000 pores. In an aspect, the plurality of poresincludes over 100,000 pores. In an aspect, the number of pores isdependent upon the manufacturing process. For example, forming theplurality of pores by manufacturing the first hollow cylinder from aporous material may include substantially more pores than forming theplurality of pores by machining the pores into the first hollowcylinder.

In an aspect, the plurality of pores is distributed over the entirety ofthe first hollow cylinder. In an aspect, the plurality of pores isdistributed over a portion of the first hollow cylinder. For example,the plurality of pores can be distributed towards the first end of thefirst hollow cylinder. For example, the plurality of pores can bedistributed towards the second end of the first hollow cylinder. Forexample, the plurality of pores can be concentrated to side of the firsthollow cylinder.

In an aspect, the plurality of pores includes pores of at least onefirst size and pores of at least one second size. The plurality of poresof the first size may be distributed in a first location along thelength of the first hollow cylinder and the plurality of pores of thesecond size may be distributed in a second location along the length ofthe first hollow cylinder. In an aspect, the plurality of pores includeat least one first set of pores at a first angle relative to the centralaxis of the first hollow cylinder and at least one second set of poresat a second angle relative to the central axis of the first hollowcylinder. The plurality of pores at the first angle may be distributedin a first location along the length of the first hollow cylinder andthe plurality of pores at the second angle may be distributed in asecond location along the length of the first hollow cylinder.

In an aspect, each of the plurality of pores is machined into the firsthollow cylinder. In an aspect, each of the plurality of pores ismachined into the first hollow cylinder with a drill. In an aspect, eachof the plurality of pores is machined into the first hollow cylinderusing pins and/or needles. For example, the plurality of pores can bemachined into the first hollow cylinder using a rotary pinnedperforation roller with either cold or hot pins. In an aspect, each ofthe plurality of pores is machined into the first hollow cylinder with alaser. Non-limiting examples of lasers for laser cutting and/or boringinclude CO₂ lasers, neodymium (Nd) lasers, or neodymiumyttrium-aluminum-garnet (Nd-YAG) lasers. In an aspect, each of theplurality of pores is machined into the first hollow cylinder using awaterjet cutter. For example, each of the plurality of pores can bemachined into the first hollow cylinder using a waterjet cutter with orwithout an added abrasive, e.g., garnet or aluminum oxide.

Penetrating device 100 includes second hollow cylinder 206. In anaspect, the second hollow cylinder is formed from stainless steel. In anaspect, the second hollow cylinder is formed from at least one of metal,alloy, plastic, glass, polymer, or ceramic. Non-limiting examples ofstainless steel, metals, alloys, plastics, glass, polymers, and ceramicshave been described above herein. In an aspect, the second hollowcylinder is formed from the same material as the first hollow cylinder.In an aspect, the second hollow cylinder is formed from a material thatdiffers from that used to form the first hollow cylinder.

In an aspect, the cross-sectional diameter of the second hollow cylinderis about 5 millimeters to about 0.2 millimeters. For example, thecross-section diameter of the first hollow cylinder can be 5millimeters, 4.8 millimeters, 4.6 millimeters, 4.4 millimeters, 4.2millimeters, 4.0 millimeters, 3.8 millimeters, 3.6 millimeters, 3.4millimeters, 3.2 millimeters, 3.0 millimeters, 2.8 millimeters, 2.6millimeters, 2.4 millimeters, 2.2 millimeters, 2.0 millimeters, 1.8millimeters, 1.6 millimeters, 1.4 millimeters, 1.2 millimeters, 1.0millimeters, 0.9 millimeters, 0.8 millimeters, 0.7 millimeters, 0.6millimeters, 0.5 millimeters, 0.4 millimeters, 0.3 millimeters, or 0.2millimeters. In an aspect, the cross-sectional diameter of the secondhollow cylinder is about 0.5 centimeters to about 30 centimeters. In anaspect, the cross-sectional diameter of the second hollow cylinder isless than the cross-sectional diameter of the first hollow cylinder. Forexample, the cross-sectional diameter of the second hollow cylinder isappropriately sized relative to the first hollow cylinder to allow thesecond hollow cylinder to be disposed within the first hollow cylinder.In an aspect, the cross-sectional diameter of the second hollow cylinderrelative to the cross-sectional diameter of the first hollow cylinderdictates the thickness of the internal fluid conduit.

Penetrating device 100 includes substantially ring-shaped end piece 212.The substantially ring-shaped end piece is configured to attach to thefirst end of the first hollow cylinder and to the first end of thesecond hollow cylinder to form an enclosed or sealed end to the internalfluid conduit formed between the first and second hollow cylinders. Inan aspect, the substantially ring-shaped end piece is formed from atleast one of stainless steel, metal, alloy, plastic, glass, polymer, orceramic. In an aspect, the substantially ring-shaped end piece and thesecond hollow cylinder are substantially non-porous. For example, thesubstantially ring-shaped end piece and the second hollow cylinder aresubstantially impervious to the first fluid composition as it flows fromthe first fluid reservoir portion through the internal fluid conduit andout at least one of the plurality of pores along the length of the firsthollow cylinder. In an aspect, the first hollow cylinder, the secondhollow cylinder, and the substantially ring-shaped end piece are formedfrom the same material. In an aspect, the first hollow cylinder, thesecond hollow cylinder, and/or the substantially ring-shaped end pieceare formed as a single unit. For example, the first hollow cylinder, thesecond hollow cylinder, and the substantially ring-shaped end piece canbe formed using one of the fabrication methods described above herein.In an aspect, the first hollow cylinder, the second hollow cylinder,and/or the substantially ring-shaped end piece are formed from differentmaterials. In an aspect, the first hollow cylinder, the second hollowcylinder, and the substantially ring-shaped end piece are formed asseparate pieces and connected together. For example, the first hollowcylinder, the second hollow cylinder, and/or the substantiallyring-shaped end piece can be formed as separate pieces and gluedtogether with an adhesive. Alternatively, the separate pieces can beadhered together using a heat welding method, e.g., to melt and/or fusetogether the separate pieces. Alternatively, the separate pieces caninclude male and/or female connector parts for use in snapping theseparate pieces together.

In an aspect, the outer edge of the substantially ring-shaped end pieceis secured to the first hollow cylinder at a location that is not thefirst end of the first hollow cylinder and the inner edge of thesubstantially ring-shaped end piece is secured to the second hollowcylinder at a location that is not the first end of the second hollowcylinder. For example, the substantially ring-shaped end piece can besecured to the first and second hollow cylinders at a location betweenthe first ends and the second ends of the first and second hollowcylinders along the length of the first and second hollow cylinders. Forexample, the substantially ring-shaped end piece can be secured to thefirst and second hollow cylinders at a location equidistant between thefirst and second ends of the first and second hollow cylinders.

First hollow cylinder 200 and second hollow cylinder 206 andsubstantially ring-shaped end piece 212 form penetrating edge 130. In anaspect, the penetrating edge includes a sharp piercing edge. In anaspect, the penetrating edge includes a sharp beveled edge. In anaspect, the penetrating edge includes at least one sharp edge able topierce a material. In an aspect, the penetrating edge includes astandard bevel. In an aspect, the penetrating edge includes a shortbevel. In an aspect, the penetrating edge includes a true short bevel.In an aspect, the penetrating edge includes a cone needle tip. In anaspect, the penetrating edge includes a bias grind edge, a vet pointedge, a lancet point edge, a deflected point edge, a razor edge, a probepoint (blunt end) edge, a trocar edge, a diamond point edge, a Trephineedge, or a Menghini edge. In an aspect, the penetrating edge includes atleast one sharp edge able to pierce metal, wood, concrete, plastic,polymer, fiberglass, resin, acrylic, latex, rubber, paper, or fabric.

In an aspect, the penetrating edge includes at least one sharp edge ableto pierce a body tissue of an animal. In an aspect, the penetrating edgeincludes at least one sharp edge able to pierce skin, endothelium,muscle, adipose, bone, cartilage, eye tissue, neural tissue, or internalorgan tissue. In an aspect, the penetrating edge includes at least onesharp edge able to pierce a plant tissue or environs. In an aspect, thepenetrating edge includes at least one sharp edge able to pierce anindustrial material.

Penetrating device 100 includes connector portion 140. The second end ofconnector portion 140 is associated with the first fluid reservoirportion. Connector portion 140 is configured to attach the penetratingportion of penetrating device 100 to the first and second fluidreservoir portions. In an aspect, the first fluid reservoir portion 232is attached to the second end of connector portion 140. In an aspect,connector portion 140 forms a seal with at least a portion of a walldefining the first fluid reservoir portion 232. In an aspect, the sealis a frictional seal. For example, at least a part of the connectorportion and at least a part of the first fluid reservoir portion can besized to fit into one another, e.g., through a male/female coupling. Inan aspect, the seal is an adherent seal. For example, at least a part ofthe connector portion and at least a part of the first fluid reservoirportion may be glued or otherwise secured to one another.

In an aspect, connector portion 140 includes a fitting. For example, theconnector portion can include a fitting that enables attachment to thefirst fluid reservoir portion. In an aspect, the connector portion 140includes a slip-tip fitting. In an aspect, the connector portion issized to slip over an appropriately sized portion of the first fluidreservoir portion. For example, the connector portion can include aninner diameter just large enough for insertion of a portion of the firstfluid reservoir portion. In an aspect, the connector portion is sized toslip into an appropriately sized portion of the first fluid reservoirportion. For example, the connector portion can include an outerdiameter just small enough to slip into a portion of the first fluidreservoir portion. In an aspect, connector portion 140 includes a Luerlock fitting. For example, the connector portion and/or a portion of thefirst fluid reservoir portion can include threads that allow the twoportions to be connected to one another, e.g., by screwing the matchedthreads together. In an aspect, the connector portion includes externalthreads while the first fluid reservoir portion includes internalthreads, such that the connector portion screws on over a portion of thefirst fluid reservoir portion. In an aspect, the connector portionincludes internal threads while the first fluid reservoir portionincludes external threads, such that the connector portion screws into aportion of the first fluid reservoir portion.

In an aspect, connector portion 140 is manufactured from metal or metalalloy, e.g., stainless steel. In an aspect, connector portion 140 ismanufactured from plastic. In an aspect, connector portion 140 ismanufactured from plastic using an injection molding technique. In anaspect, the connector portion is formed from the same material as thefirst hollow cylinder. In an aspect, the connector portion is formedfrom a material that differs from the material used to form the firsthollow cylinder. In an aspect, the connector portion and the firsthollow cylinder are formed as one piece. In an aspect, the connectorportion and the first hollow cylinder are formed as separate pieces andsubsequently secured to one another, e.g., by adhesive or heat welding.

Reservoir portion 120 further includes second fluid reservoir portion234 associated with the second end of second hollow cylinder 206. Secondfluid reservoir portion 234 is in fluid communication with the lumendefined by the second hollow cylinder. In an aspect, the second fluidreservoir portion is configured to hold a second fluid composition,e.g., a vaccine, therapeutic agent, dye, or other fluid composition. Forexample, the second fluid reservoir portion can hold a vaccine,therapeutic agent, and/or dye intended for delivery to an animalsubject. In an aspect, the second fluid reservoir portion is configuredto hold a captured sample, e.g., a blood sample, a marrow sample, and/ora tissue sample. For example, the second fluid reservoir portion canhold a captured sample drawn up or aspirated from an animal subject. Inan aspect, the second fluid reservoir portion is configured to hold asecond fluid composition at a first time point and a captured sample ata second time point. For example, the second fluid reservoir portion ofthe penetrating device can be used for a wash aspirate in which a washsolution, e.g., saline, is delivered from the second fluid reservoirportion, and a captured sample, e.g., a nasal sample including the washsolution, is aspirated back into the second fluid reservoir portion.

In an aspect, second fluid reservoir portion 234 forms a seal with atleast a portion of the second end of second hollow cylinder 206. In anaspect, the seal is a frictional seal. For example, at least a part ofthe second fluid reservoir portion and at least a part of the second endof second hollow cylinder 206 can be sized to fit into one another,e.g., through a male/female coupling. In an aspect, the seal is anadherent seal. For example, at least a part of the second fluidreservoir portion and at least a part of the second end of second hollowcylinder 206 may be glued or otherwise secured to one another.

In an aspect, the first fluid reservoir portion includes a first hollowtube and the second fluid reservoir portion includes a second hollowtube, the second hollow tube disposed within the first hollow tube. Forexample, the first fluid reservoir portion and the second fluidreservoir portion can be concentric to one another. See, e.g., U.S.Patent Application No. 2007/0083155 to Muller and titled “Multi-lumeninjection apparatus,” which is incorporated herein by reference.

In an aspect, the first fluid reservoir portion and the second fluidreservoir portion are parallel to one another. In an aspect, the firstfluid reservoir portion and the second fluid reservoir portion areparallel and concentric to one another, as illustrated in FIGS. 2-4. Inan aspect, the first fluid reservoir portion and the second fluidreservoir portion are parallel to one another but not concentric. Forexample, the first fluid reservoir portion can include a first hollowtube and the second fluid reservoir portion can include a second hollowtube, the first hollow tube and the second hollow tube substantiallyparallel to one another. See, e.g., U.S. Pat. No. 6,972,005 to Boehm &Melnick titled “Dual chamber syringe and dual lumen needle,” which isincorporated herein by reference.

FIGS. 5A and 5B illustrate aspects of a penetrating device includingparallel first and second fluid reservoir portions. FIG. 5A is anexternal view of penetrating device 500 including a penetrating portion510, a connector portion 520, and a fluid reservoir portion 530.Penetrating portion 510 includes a plurality of pores 512 and apenetrating edge 514. Connector portion 520 is configured to connectpenetrating portion 510 to fluid reservoir portion 530. Fluid reservoirportion 530 includes first fluid reservoir portion 532 for holding afirst fluid composition and a second fluid reservoir portion 534. In anaspect, the second fluid reservoir portion is configured to hold asecond fluid composition. In an aspect, the second fluid reservoirportion is configured to hold a captured sample. First fluid reservoirportion 532 includes first initiator 536 configured to induce flow ofthe first fluid composition from first fluid reservoir portion 532,through an internal fluid conduit, and out at least one of the pluralityof pores 512. Second fluid reservoir portion 534 includes a secondinitiator 538 configured to induce flow into or out of second fluidreservoir portion 534. FIG. 5B illustrates further aspects ofpenetrating device 500. Shown is a longitudinal cross-section throughpenetrating device 500. Penetrating device 500 includes a first hollowcylinder 540 having a first end 542 and a second end 544, first hollowcylinder 540 including plurality of pores 512. Penetrating device 500includes second hollow cylinder 546 having a first end 548 and a secondend 550, second hollow cylinder 546 disposed within first hollowcylinder 540 and substantially coaxial to first hollow cylinder 540. Asubstantially ring-shaped end piece 552 is attached to the first end 542of first hollow cylinder 540 and first end 548 of second hollow cylinder546, first hollow cylinder 540, second hollow cylinder 546, andsubstantially ring-shaped end piece 552 forming penetrating edge 514.Internal fluid conduit 554 is defined by a space between first hollowcylinder 540 and substantially coaxial second hollow cylinder 546,internal fluid conduit 554 in fluid communication with the plurality ofpores 512 along the length of first hollow cylinder 540. Connectorportion 520 includes a first end 556 attached proximal to the second end544 of first hollow cylinder 540. Lumen 558 is defined by second hollowcylinder 546 and is in fluid communication with penetrating edge 514.First fluid reservoir portion 532 is attached to a portion of connectorportion 520 and is in fluid communication with connector portion 520 andinternal fluid conduit 554. Second fluid reservoir portion 534 isattached to the second end 550 of second hollow cylinder 546 and is influid communication with lumen 558 defined by second hollow cylinder546. First initiator 536 is configured to induce flow of the first fluidcomposition from first fluid reservoir portion 532, through internalfluid conduit 554, and out at least one of the plurality of pores 512.Second initiator 538 is configured to induce flow into or out of secondfluid reservoir portion 534, through lumen 558 defined by second hollowcylinder 546.

In an aspect, the first fluid reservoir portion is in fluidcommunication with the connector portion and the internal fluid conduitthrough a length of tubing. In an aspect, the second fluid reservoirportion is in fluid communication with the lumen defined by the secondhollow cylinder through a length of tubing. FIGS. 6A and 6B illustratean example of a penetrating device including a first fluid reservoirportion and/or a second fluid reservoir portion in fluid communicationrespectively with a connector portion and a lumen defined by the secondhollow cylinder. FIG. 6A is a schematic showing an external view ofpenetrating device 600. Penetrating device 600 includes penetratingportion 610, connector portion 620, first fluid reservoir portion 630,and second fluid reservoir portion 640. Penetrating portion 610 includesplurality of pores 612 and penetrating edge 614. Connector portion 620includes lid portion 650. Lid portion 650 includes first inlet 652 witha first tubing 654 attached to first fluid reservoir portion 630 andsecond inlet 656 attached with a second tubing 658 to second fluidreservoir portion 640. FIG. 6B is a schematic of a longitudinalcross-section of penetrating device 600. Penetrating device 600 includesfirst hollow cylinder 660 including a plurality of pores 612; secondhollow cylinder 665 disposed within first hollow cylinder 660 andsubstantially coaxial to first hollow cylinder 660; substantiallyring-shaped end piece 670 attached to a first end 662 of first hollowcylinder 660 and to a first end 668 of second hollow cylinder 665,wherein first hollow cylinder 660, second hollow cylinder 665, andsubstantially ring-shaped end piece 670 form penetrating edge 614;internal fluid conduit 675 defined by a space between first hollowcylinder 660 and second hollow cylinder 665, internal fluid conduit 675in fluid communication with the plurality of pores 612; connectorportion 620 disposed over and coaxial to a region 622 of second hollowcylinder 665, a first end 624 of connector portion 620 attached proximalto a second end 664 of first hollow cylinder 660, connector portion 620in fluid communication with internal fluid conduit 675; and a lumen 680defined by second hollow cylinder 665. Connector portion 620 furtherincludes lid portion 650 which is secured to a second end 669 of secondhollow cylinder 665 to form a seal and with a second end 626 ofconnector portion 620 to form a seal. Lid portion 650 includes inlet 652with tubing 654 in fluid communication with first fluid reservoirportion 630 and inlet 656 with tubing 658 in fluid communication withsecond fluid reservoir portion 640.

In an aspect, the first fluid reservoir portion is configured forholding a first fluid composition. In an aspect, the first fluidcomposition includes at least one lubricant. In an aspect, the firstfluid composition includes at least one lubricant intended to makepiercing of a material by the penetrating portion of the penetratingdevice easier. In an aspect, the at least one lubricant includes a formof silicone. For example, the at least one lubricant can include atleast one of silicone oil, silicone grease, silicone rubber, or siliconeresin.

In an aspect, the at least one lubricant includes a biocompatiblelubricant for use in piercing a tissue of a mammalian subject. Forexample, Dow Corning® MDX4-4159, a silicone fluid, has been describedfor coating hypodermic needles. See, e.g., U.S. Patent Application No.2012/0059333 to Singhal titled “Apparatus and methods for reuse ofinjection needle for home users,” which is incorporated herein byreference. For example, the biocompatible lubricant can includeEndo-Glide™, a lubricant gel approved for used by the United States Food& Drug Administration that is biocompatible with tissues and all hollowviscera. For example, the biocompatible lubricant can includepolyethylene glycol, for which a range of average molecular weights maybe used, such as about 200 to about 600 g/mole. See, e.g., U.S. Pat. No.6,259,953 to Lucchesi et al. titled “Cardiac lead with active fixationand biocompatible lubricant,” which is incorporated herein by reference.In an aspect, the at least one lubricant includes a natural gum productwith bacteriostatic properties. For example, the at least one lubricantcan include a natural gum product with bacteriostatic properties suchas, for example, Surgilube Bacteriostatic Sterile Lubricating Jelly™. Inan aspect, the at least one lubricant includes a biocompatible lubricantcomprising a biological agent. For example, the at least one lubricantincludes liposomes or other lipid-based or fat-based agents. Forexample, the at least one lubricant includes hyaluronan.

In an aspect, the first fluid composition of the first fluid reservoirportion includes at least one of an anesthetic or an analgesic. In anaspect, the first fluid composition includes at least one localanesthetic, non-limiting examples of which includes lidocaine, procaine,amethocaine, cocaine, prilocaine, bupivacaine, levobupivacaine,ropivacaine, mepivacaine, or dibucaine. In an aspect, the first fluidcomposition includes at least one analgesic. Non-limiting examples ofanalgesics include non-steroidal anti-inflammatory drugs, e.g.,salicylates or ibuprofen, opioids, e.g., morphine, codeine, oxycodone,or hydrocodone, paracetamol, acetaminophen, or cyclooxygenaseinhibitors, e.g., COX-2 inhibitors.

In an aspect, the first fluid composition of the first fluid reservoirportion includes at least one antiseptic. In an aspect, the at least oneantiseptic includes at least one disinfectant and/or sterilant.Non-limiting examples of antiseptics include isopropanol, silvercompounds, ethanol, povidone, iodine, glutaraldehyde, formaldehyde,chlorhexidine gluconate, sodium hypochlorite, quaternary ammoniumscompounds, hydrogen peroxide, and phenols.

In an aspect, the first fluid composition of the first fluid reservoirportion includes at least one antimicrobial agent. In an aspect, thefirst fluid composition includes at least one of an antibacterial agent,an antifungal agent, or an antiviral agent. In an aspect, the firstfluid composition includes at least one antibacterial agent configuredto prevent or minimize a bacterial infection at an injection site.Non-limiting examples of antibacterial agents commonly used for topicalapplications include benzoyl peroxide, sodium sulfacetamide,erythromycin, mupirocin, retapamulin, bacitracin, neomycin, polymyxinb/e, silver sulfadiazine, or tetracycline. In an aspect, the first fluidcomposition includes at least one antiviral agent configured to preventor treat a viral infection at an injection site. Non-limiting examplesof antiviral agents commonly used for topical applications includeacyclovir, docosanol, famciclovir, imiquimod, penciclovir, valacyclovir,and vidarabine. In an aspect, the first fluid composition includes atleast one antifungal agent configured to prevent or treat a fungalinfection at an injection site. Non-limiting examples of antifungalagents commonly used for topical applications include clotrimazole,amphotericin B, butaconazole, butenafine, ciclopirox olamine, econazole,ketoconazole, miconazole, naftifine, natamycin, nystatin, oxiconazole,sulconazole, terbinafine, terconazole, tioconazole, and tolnaftate.

In an aspect, the first fluid composition of the first fluid reservoirportion includes at least one anticoagulant. In an aspect, the firstfluid composition includes at least one of an antithrombotic,fibrinolyitc, or thrombolytic agent to prevent blood coagulation.Non-limiting examples of anticoagulants include coumarins, e.g.,warfarin; heparin and derivatives thereof, e.g., low molecular weightheparin, fondaparinux, or idraparinux; factor Xa inhibitors, e.g.,rivaroxaban, apixaban, or edoxaban; or thrombin inhibitors, e.g.,hirudin, lepirudin, bivalirudin, argatroban, or dabigatran.

In an aspect, the first fluid composition of the first fluid reservoirportion includes at least one antihemorrhagic agent. In an aspect, thefirst fluid composition includes at least one substance that promoteshemostasis or stops bleeding. In an aspect, the at least oneantihemorrhagic agent includes at least one styptic, e.g., an agent thatcontracts tissue to seal injured blood vessels. In an aspect, the atleast one antihemorrhagic agent causes vasoconstriction and/or plateletaggregation. Non-limiting examples includes microfibrillar collagen,chitosan, anhydrous aluminum sulfate, and microporous zeolitealuminosilicate minerals.

In an aspect, the first fluid composition of the first fluid reservoirportion includes at least one sealant. In an aspect, the at least onesealant is formulated to seal up the puncture site after withdrawal ofthe penetrating portion from the pierced tissue. In an aspect, thesealant can include an adhesive. In an aspect, the sealant can include abiocompatible sealant. For example, the sealant can include at least oneof cyanoacrylate, octyl-2-cyanoacrylate, or n-butyl-cyanoacrylate. Forexample, the sealant can include Dermabond® or Histoacryl®. For example,the sealant can include fibrin glue.

In an aspect, the first fluid composition of the first fluid reservoirportion includes at least one treatment agent. In an aspect, the atleast one treatment agent can include at least one adjuvant to atherapeutic or preventative agent. For example, the at least onetreatment agent can include a cytokine or a chemokine, e.g., for usewith a vaccine. For example, the at least one treatment agent caninclude an adjuvant for a vaccine. Non-limiting examples of adjuvantsinclude aluminum gels, aluminum salts, oil-in-water emulsions, e.g.,squalene-oil-in-water, water-in-oil emulsions, Freund's adjuvant,pattern recognition receptor ligands, e.g., Toll-Like Receptor (TRL)ligands, pathogens associated molecular patterns (PAMPs), or otheragents capable of enhancing an immune response to a vaccine.

In an aspect, the first fluid composition is incorporated into the firstfluid reservoir portion at the time of manufacture. For example, thefirst fluid composition can be incorporated into the first fluidreservoir portion by suction using a first initiator, e.g., a plunger,and the device locked to a position to prevent loss of the first fluidcomposition prior to use. For example, the first fluid composition canbe incorporated into the first fluid reservoir portion by dispensing thefirst fluid composition into the first fluid reservoir portion andsealing the first fluid reservoir portion.

In an aspect, the first fluid composition is incorporated into the firstfluid reservoir portion at the time of use. For example, the first fluidcomposition can be incorporated into the first fluid reservoir portionby suction using a first initiator, e.g., a plunger. For example, thepenetrating portion can be inserted through the septum of an injectionvial and a first fluid composition, e.g., a lubricant and/or ananalgesic, drawn up into the first fluid reservoir portion. For example,the first fluid composition can be incorporated into the first fluidreservoir portion by dispensing the first fluid composition into thefirst fluid reservoir portion. For example, the first fluid compositioncan be included in a first fluid reservoir portion that is a cartridgeconnected just prior to use to the penetrating portion of thepenetrating device. In an aspect, the cartridge is connected directly,e.g., fitted to the second end of the of the connector portion, orindirectly, e.g., through a flow conduit that includes surgical tubing.

Penetrating device 100 includes second fluid reservoir portion 234.Second fluid reservoir portion 234 is associated with the second end ofthe second hollow cylinder and is in fluid communication with the lumendefined by the second hollow cylinder. In an aspect the second fluidreservoir portion is configured to hold a captured sample. In an aspectthe second fluid reservoir portion provides vacuum for use in capturinga captured sample, for example by suction using a second initiator,e.g., a plunger. In an aspect, the penetrating device is a bloodsampling device and the second fluid reservoir portion holds aspiratedblood. In an aspect, the penetrating device is an aspiration device. Forexample, the penetrating device is an aspiration device for acquiring anaspiration from an organ or viscera, e.g., aspiration of ascites fluid,aspiration of fluid surrounding an organ, or bone marrow aspiration. Inan aspect, the penetrating device is a biopsy device, and the secondfluid reservoir portion is configured to hold a captured biopsy sampleor provides suction for capturing and holding a captured biopsy sample.For example, the penetrating device is a biopsy device for use inacquiring a tissue biopsy, e.g., from a soft tissue or bone, to look foran indication of a pathology, e.g., abnormal cells indicative of cancer,or the presence of a microbe indicating an infection.

In an aspect, the second fluid reservoir portion 234 of penetratingdevice 100 is configured to hold a second fluid composition. In anaspect, the second fluid composition includes at least one vaccine.Non-limiting examples of vaccines include vaccines against small pox,hepatitis A, hepatitis B, polio, mumps, measles, rubella, diphtheria,pertussis, tetanus, HiB, chickenpox, rotavirus, influenza, meningococcaldisease, pneumonia, typhoid, anthrax, yellow fever, and the like. It isanticipated that other vaccines currently in development for humanimmunodeficiency virus (HIV) and cancer, for example, will be of use inthe systems and methods described herein.

In an aspect, the second fluid composition includes at least onetherapeutic agent. In an aspect, the at least one therapeutic agentincludes at least one of an anti-inflammatory agent, an antimicrobialagent, a chemotherapeutic agent, or a diabetes treatment agent. In anaspect, the at least one anti-inflammatory agent includes at least oneinjectable antibody, cytokine, non-steroidal anti-inflammatory drug, orsteroidal anti-inflammatory drug. Non-limiting examples ofanti-inflammatory agents include teriparatide, etanercept, interferon,abatacept, anakinra, bevacizumab, cetuximab, cyclophosphamide,gemtuzumab, muromonab-CD3, omalizumab, pegademase, immune globulin,tacrolimus, or tositumomab. In an aspect, the at least one antimicrobialagent includes at least one of an antibiotic, antifungal agent, orantiviral agent. Non-limiting examples of antibiotics includepenicillins, e.g., penicillin, ampicillin, piperacillin; cephalosporinsand other beta-lactam drugs, e.g., cefazolin, ertapenem; tetracyclines,e.g., doxycycline; macrolides, e.g., erythromycin; clindamycin;aminoglycosides, e.g., streptomycin, gentamicin; spectinomycin;sulfonamides; quinolones and fluoroquinolones. Non-limiting examples ofantiviral agents include protease inhibitors, neuraminidase inhibitors,integrase inhibitors, reverse transcriptase inhibitors, viral entryinhibitors, uncoating inhibitors, and translation inhibitors. In anaspect, the at least one hormone includes at least one of a hypothalamicor pituitary hormone, synthetic analogs, and/or antagonist thereof,e.g., adrenocorticotropic hormone, corticotropin-releasing hormone,follicle stimulating hormone, gonadotropin-releasing hormone andsynthetic analogs, luteinizing hormone, prolactin; at least one of anadrenocoricosteroid, synthetic analogs, and/or antagonists thereof,e.g., dexamethasone, hydrocortisone, prednisolone, methylprednisolone,triamicinolone; gonadal hormones, e.g., estrogens, progestins,androgens, and anabolic steroids; glucagon and analogs thereof. In anaspect, at least one cancer chemotherapeutic or associated therapyincludes at least one of alpha interferon, erythropoietin andderivatives thereof, colony stimulating factor and analogs thereof,somatostatin and analogs thereof.

In an aspect, the at least one diabetes treatment agent includes a formof insulin. Non-limiting examples of insulin include rapid actinginsulin, short-acting insulins, intermediate-acting insulins, premixedinsulins, or long-acting insulins. Commercial sources of insulin areavailable from, e.g., Eli Lilly (Indianapolis, Ind.), Sanofi-Aventis(Bridgewater N.J.), Novo Nordisk Inc. (Princeton, N.J.), or Pfizer (NewYork, N.Y.).

In an aspect, the second fluid composition includes at least onecosmetic enhancement agent. In an aspect, the second fluid compositionincludes at least one neurotoxin, subcutaneous volume enhancer, ordermal filler. In an aspect, the at least one neurotoxin includesbotulinum toxin. Non-limiting examples of botulinum toxin includeonabotulinumtoxinA, abotulinumtoxinA, incobotulinymtoxinA,rimabotulinumtoxinB and like agents (see, e.g., Park et al., Clin.Ophthalmol. (2011) 5:725-732, which is incorporated herein byreference). In an aspect, the at least one dermal filler includes atleast one collagen filler. Non-limiting examples of bovine-, porcine-,or human-derived collagen fillers include Artefill,Cosmoplast/Cosmoderm, Evolence, and Zyderm/Zyplast. In an aspect, the atleast one dermal filler includes at least one hyaluronic acid filler.Non-limiting examples of hyaluronic fillers include Belotero Balance(from Merz Aesthetics); Hyalaform, Juvederm Ultra and Juvederm UltraPlus (from Allergan, Inc.); Perlane and Restylane (from MedicisAesthetics Inc.) PREVELLE and Puragen (from Mentor Corp.). Othernon-limiting examples of subcutaneous volume enhancers or dermal fillersinclude adipose, fibroblasts, calcium microspheres, or poly L lacticacid.

In an aspect, the second fluid composition includes a dye, for example adye for injection into an internal organ prior to further examinationsuch as radiography, e.g., transhepatic cholangiography.

In an aspect, the second fluid composition includes a wash solution,e.g., a saline solution, for an aspiration wash. For example, the secondfluid reservoir portion can include a wash solution that is delivered toa tissue and subsequently aspirated back into the second fluid reservoirportion along with aspirated captured sample.

In an aspect, the second fluid composition of the second fluid reservoirportion is configured for at least one of percutaneous administration,intravenous administration, subcutaneous administration, intraocularadministration, intraosseus administration, epidural administration,intraarticular administration, intraperitoneal administration, intraoraladministration, or intramuscular administration.

In an aspect, the second fluid composition is incorporated into thesecond fluid reservoir portion at the time of manufacture. For example,the second fluid composition can be incorporated into the second fluidreservoir portion by suction using a second initiator, e.g., a plunger,and the device locked to a position to prevent loss of the second fluidcomposition prior to use. For example, the second fluid composition canbe incorporated into the second fluid reservoir portion by dispensingthe second fluid composition into the second fluid reservoir portion andsealing the second fluid reservoir portion.

In an aspect, the second fluid composition is incorporated into thesecond fluid reservoir portion at the time of use. For example, thesecond fluid composition can be incorporated into the second fluidreservoir portion by suction using a second initiator, e.g., a plunger.For example, the penetrating portion can be inserted through the septumof an injection vial and a vaccine and/or therapeutic agent drawn upinto the second fluid reservoir portion. For example, the second fluidcomposition can be incorporated into the second fluid reservoir portionby pouring the second fluid composition into the second fluid reservoirportion. For example, the second fluid composition can be included in asecond fluid reservoir portion that is a cartridge connected just priorto use to the penetrating portion of the penetrating device. In anaspect, the cartridge is connected directly, e.g., fitted to the secondend of the second hollow cylinder, or indirectly, e.g., through a flowconduit that includes surgical tubing.

Penetrating device 100 includes first initiator 160 and second initiator170. The first initiator is configured to induce flow of the first fluidcomposition from the first fluid reservoir portion, through the internalfluid conduit, and out at least one of the plurality of pores. Thesecond initiator is configured to induce flow into or out of the secondfluid reservoir portion, through the lumen defined by the second hollowcylinder. In an aspect, at least one of the first initiator or thesecond initiator includes an actuator.

In an aspect, at least one of the first initiator or the secondinitiator includes a plunger. In an aspect, the plunger includes aspectsof a syringe plunger, e.g., a thumb press, a plunger rod, and a stopperthat fits tightly within the first and/or second fluid reservoirportion. The thumb press can be used to pull out and push in theplunger. For example, the first initiator and/or the second initiatorcan include a plunger with a rubber stopper portion that fits tightly inrespectively the first fluid reservoir portion and/or the second fluidreservoir portion. In an aspect, the plunger is formed from glass andincludes a sintered surface. For example, the first initiator and/or thesecond initiator can include a plunger formed from sintered glass foruse with a first fluid reservoir portion and/or a second fluid reservoirportion formed from glass. In an aspect, the plunger is formed frommetal. For example, the first initiator and/or the second initiator canbe formed from metal, e.g., stainless steel.

In an aspect, the first initiator is a first plunger and the secondinitiator is a second plunger. In an aspect, the first initiator is afirst plunger and the second initiator is a second plunger, the firstplunger sized to fit within the first fluid reservoir portion and toinduce flow of the first fluid composition, the second plunger sized tofit within the second fluid reservoir portion and to induce flow of thesecond fluid composition. In an aspect, the first initiator is a firstplunger, the first plunger substantially ring-shaped and sized to fit ina space between a first hollow tube and a second hollow tube forming thefirst fluid reservoir portion, and wherein the second initiator is asecond plunger, the second plunger sized to fit in a second hollow tubeforming the second fluid reservoir portion. In an aspect, the firstplunger and the second plunger are concentric. FIGS. 7A and 7Billustrate aspects of a first and second plunger of a penetratingdevice. FIG. 7A shows a schematic of a portion of a first fluidreservoir portion 700 and a second fluid reservoir portion 710 of apenetrating device. First fluid reservoir portion 700 includes the spacebetween first hollow tube 715 and second hollow tube 720. Second fluidreservoir portion 710 includes the internal space of second hollow tube720. First plunger 725 includes a hollow cylindrical plunger rod 730attached at one end to cylindrical stopper 735 and at the other end tocylindrical thumb press 740, first plunger 725 disposed within firstfluid reservoir portion 700 between first hollow tube 715 and secondhollow tube 720, cylindrical stopper 735 including a hole 738,cylindrical thumb press 740 including a hole 742. Second plunger 745includes a plunger rod 750 attached at one end to stopper 755 and at theother end to thumb press 760, second plunger 745 disposed within secondreservoir portion 710 within second hollow tube 720, plunger rod 750 isdisposed within hole 742 of cylindrical thumb press 740 and stopper 755is configured to pass through hole 738 of cylindrical stopper 735.

In an aspect, as illustrated in FIG. 7B, the first plunger can includetwo or more rods disposed in the cylindrical first fluid reservoirportion, the two or more rods attached at one end to a cylindricalstopper and at the other end to a cylindrical thumb press. FIG. 7B showsa schematic of a first fluid reservoir portion 700 and a second fluidreservoir portion 710. First fluid reservoir portion 700 includes thespace between first hollow tube 715 and second hollow tube 720. Secondfluid reservoir portion 710 includes the internal space of second hollowtube 720. First plunger 765 includes two or more plunger rods 770attached at one end to cylindrical stopper 735 and at the other end tocylindrical thumb press 740, first plunger 725 disposed within firstfluid reservoir portion 700 between first hollow tube 715 and secondhollow tube 720, cylindrical stopper 735 including a hole 738,cylindrical thumb press 740 including a hole 742; second plunger 745includes a plunger rod 750 attached at one end to stopper 755 and at theother end to thumb press 760, second plunger 745 disposed within secondreservoir portion 710 within second hollow tube 720, plunger rod 750 isdisposed within hole 742 of cylindrical thumb press 740 and stopper 755is configured to pass through hole 738 of cylindrical stopper 735.

In an aspect, at least one of the first initiator or the secondinitiator includes a pump. In an aspect, a first pump is configured toinduce flow of the first fluid composition from the first fluidreservoir portion, through the internal fluid conduit, and out at leastone of the plurality of pores. In an aspect, the second pump isconfigured to induce flow into or out of the second fluid reservoirportion, through the lumen defined by the second hollow cylinder. In anaspect, at least one of the first pump or the second pump includes apositive displacement pump. Non-limiting examples of positivedisplacement pumps include rotary pumps, e.g., gear or screw pumps,peristaltic pumps with flexible tubing, plunger pumps,compressed-air-powered double-diaphragm pumps, and centrifugal pumps. Inan aspect, the pump includes a syringe pump, syringe driver, or infusionpump. In an aspect, the second pump includes an aspiration pump or asuction pump to induce flow into the second fluid reservoir portion. Inan aspect, at least one of the first pump or the second pump includes avalveless pump. In an aspect, a first pump pushes on the thumb press ofa first plunger and/or a second pump pushes on the thumb press of asecond plunger. In an aspect, a first pump pumps a gas, e.g., air, intothe first fluid reservoir portion to induce flow of the first fluidcomposition and a second pump pumps a gas, e.g., air, into the secondfluid reservoir portion to induce flow of a second fluid composition. Inan aspect, a first pump pumps the first fluid composition from the firstfluid reservoir portion through the internal fluid conduit and/or the asecond pump pumps a second fluid composition from the second fluidreservoir portion through the lumen defined by the second hollowcylinder of the penetrating portion. For example, a first pump caninclude a first peristaltic pump with tubing attached at one end to thefirst fluid reservoir portion and at a second end to the connectorportion of the first hollow cylinder, and a second pump can include asecond peristaltic pump with tubing attached at one end to the secondfluid reservoir portion and at a second end to the second hollowcylinder of the penetrating portion. In an aspect, a first pump pumpsthe first fluid composition from the first fluid reservoir portionthrough the internal fluid conduit and the second pump aspirates acaptured sample into the second fluid reservoir portion through thelumen defined by the second hollow cylinder.

In an aspect, the first initiator and the second initiator are operablycoupled. For example, actuating, e.g., moving, the first initiatorautomatically actuates the second initiator. In an aspect, the thumbpress of the first initiator and the thumb press of the second initiatorare operably coupled. For example, the thumb press of the firstinitiator can be physically attached to the thumb press of the secondinitiator such that moving the first initiator automatically causesmovement of the second initiator and moving the second initiatorautomatically causes movement of the first initiator. For example, afirst pump, e.g., an electric pump, can be operably coupled to a secondpump such that actuating, e.g., turning on, the first pump actuates thesecond pump.

In an aspect, the first initiator and the second initiator are operablyindependent. In an aspect, a first plunger and a second plunger areoperably independent. In an aspect, the thumb press of the firstinitiator and the thumb press of the second initiator are operablyindependent. For example, the thumb press of the first initiator can bemoved independently of the thumb press of the second initiator. In anaspect, a first pump and a second pump are operably independent. Forexample, actuating the first pump does not automatically actuate thesecond pump.

FIG. 8 illustrates further aspects of a penetrating device. In anaspect, penetrating device 800 includes penetrating portion 810 andreservoir portion 820. Penetrating portion 810 includes penetrating edge830 and plurality of pores 850, connector portion 840, first initiator860, and second initiator 870. Penetrating device 800 includes at leasta portion of the internal components described in FIG. 2 for penetratingdevice 100, including a first fluid reservoir portion for holding afirst fluid composition and associated with first initiator 860 and asecond fluid reservoir portion associated with second initiator 870. Inaddition, penetrating device 800 includes computing component 880.Computing component 880 includes a microprocessor. In an aspect, themicroprocessor includes a central processing unit (CPU) on a singleintegrated circuit. In an aspect, the microprocessor is programmable,including circuitry configured to accept digital data as input, processit according to instructions stored in its memory, and provide resultsas output.

In an aspect, computing component 880 is operably coupled to at leastone of the first initiator 860 or the second initiator 870. For example,the computing component can be electrically wired to the first initiatorand/or the second initiator. For example, the computing component can beelectrically wired to a first spring-loaded mechanism associated withthe first initiator and to a second spring-loaded mechanism associatewith the second initiator. In an aspect, the computing component 880includes circuitry configured to controllably actuate at least one ofthe first initiator 860 or the second initiator 870. In an aspect, themicroprocessor of the computing component 880 includes one or moreinstructions for controllably actuating at least one of first initiator860 or second initiator 870. In an aspect, the microprocessor ofcomputing component 880 includes embedded software for controllablyactuating at least one first initiator 860 or second initiator 870.

In an aspect, the computing component is operably coupled to a firstinitiator that is a first pump and/or a second initiator that is asecond pump. For example, the computing component can include circuitryconfigured to send a signal, e.g., an electrical signal, to actuate afirst and/or second pump.

In an aspect, computing component 880 includes circuitry configured tocontrollably actuate first initiator 860 and second initiator 870simultaneously. In an aspect, computing component 880 includes circuitryconfigured to controllably actuate first initiator 860 and secondinitiator 870 sequentially. In an aspect, computing component 880includes circuitry configured to controllably actuate at least one offirst initiator 860 to deliver a fixed amount of the first fluidcomposition or second initiator 870 to deliver a fixed amount of asecond fluid composition.

In an aspect, penetrating device 800 further includes at least onesensor 890 operably coupled to computing component 880. In an aspect, atleast one sensor 890 is operably coupled to computing component 880through a wired connection 885. In an aspect, at least one sensor 890includes at least one of an accelerometer, a clock, a temperaturesensor, a proximity sensor, a chemical sensor, or a pressure sensor.Non-limiting examples of other sensors include at least one of a flowsensor, a viscosity sensor, a shear sensor, a pH sensor, an opticalsensor, an imaging device, an acoustic sensor, a biosensor, anelectrical sensor, or a magnetic sensor. In an aspect, at least onesensor 890 is sized for attachment to penetrating device 800. In anaspect, at least one sensor 890 includes a micro-electromechanicalsystems (MEMS) sensor.

In an aspect, the at least one sensor 890 includes at least oneaccelerometer. For example, the penetrating device can include at leastone sensor for tracking movement towards a target tissue, e.g.,accelerometers and/or proximity sensors, to indicate when the firstand/or second initiator should be actuated. For example, the at leastone sensor can include at least one chip-based accelerometer, gyroscope,magnetometers, and inertia sensor commonly used in smart devices, e.g.,smart phones. For example, the accelerometer can include one or morepiezoelectric, piezoresistive, or capacitive components for convertingmechanical motion into an electrical signal. For example, apiezoelectric accelerometer can include a piezoceramic (e.g., leadzirconate titanate) or crystals (e.g., quartz or tourmaline). Forexample, the accelerometer can include a micro electro-mechanical system(MEMS) including a cantilever beam. In an aspect, the accelerometer isused in combination with computing component 880 for an inertialnavigation system to calculate the position, orientation, and velocityof the penetrating device. Accelerometers of various sizes and types areavailable from commercial sources (e.g., from Mouser Electronics®,Mansfield, Tex.).

In an aspect, at least one sensor 890 includes at least one proximitysensor. For example, the penetrating device can include a proximitysensor for sensing proximity of the penetrating edge with a surface,e.g., a tissue surface. In an aspect, the proximity sensor can includecapacitive, inductive, magnetic, optical or ultrasonic sensing.Proximity sensors of various sizes and types are available fromcommercial sources (e.g., from Mouser Electronics®, Mansfield, Tex.).

In an aspect, at least one sensor 890 includes at least one pressuresensor. For example, the penetrating device can include a pressuresensor for sensing contact of the penetrating edge with a surface, e.g.,a tissue surface. For example, a pressure sensor can be used to detectwhen the penetrating portion of the penetrating device comes in contactwith a surface, e.g., a tissue surface. For example, the at least onepressure sensor can include a piezoresistive strain gauge. For example,the at least one pressure sensor can include a capacitive pressuresensor including a metal, ceramic, or silicon diaphragms. For example,the at least one pressure sensor can include a quartz-basedpiezoelectric pressure sensor. Pressure sensors of various sizes andtypes are available from commercial sources (e.g., from MouserElectronics®, Mansfield, Tex.).

In an aspect, at least one sensor 890 includes at least one timer. Forexample, the at least one timer can be used to measure the intervalbetween actuation of the first initiator and actuation of the secondinitiator, the actuation of the first and/or second initiator withrespect to acceleration of device, or proximity to target. In an aspect,at least one sensor 890 includes at least one clock.

In an aspect, at least one sensor 890 includes at least one temperaturesensor. For example, the penetrating device can include a temperaturesensor for sensing proximity of the penetrating edge with a heatedsurface, e.g., a skin surface. Temperature sensors or thermostats invarious sizes and types are available from commercial sources (e.g.,from Mouser Electronics®, Mansfield, Tex.).

In an aspect, at least one sensor 890 includes at least one chemicalsensor. For example, the penetrating device can include a chemicalsensor for sensing chemicals upon contact with or penetration through asurface, e.g., chemical markers on the skin surface or in the underlyingdermal layers of the skin. For example, the penetrating device caninclude a chemical sensor that is an “artificial nose” for sensing a gasphase analyte. In an aspect, the chemical sensor can include at leastone sensor responsive to changes in capacitance. See, e.g., Berggren etal., “Capacitive Biosensors,” Electroanalysis vol. 13, no. 3, 173-180,(2001), which is incorporated herein by reference. For example, one ormore sensors can include a micromechanical biosensor with a fixed-fixedbeam attached to an interdigitated capacitor (see, for example, Lim etal., “A Micromechanical Biosensor with Interdigitated CapacitorReadout,” Proceedings of the 2011 IEEE/ICME International Conference onComplex Medical Engineering, May 22-25, Harbin, China, which isincorporated herein by reference). Sensors may also include nanowirenanosensors, for example as described in Cui et al., “NanowireNanosensors for Highly Sensitive and Selective Detection of Biologicaland Chemical Species,” Science, vol. 293, 1289-1292 (2001), which isincorporated herein by reference. Sensors can include those utilizingantibodies secured to a graphene substrate. See Tehrani et al.,“Detection of Monoclonal Antibodies using Chemically Modified GraphiteSubstances,” IEEE Sensors 2010 Conference Proceedings, 428-431, (2010),which is incorporated herein by reference. In some embodiments, sensorsinclude aptamer-modified graphene field-effect transistors, see Ohno etal., “Graphene Field-Effect Transistors for Label-Free BiologicalSensors,” IEEE Sensors 2010 Conference Proceedings, 903-906, (2010),which is incorporated herein by reference. A sensor can include a fieldeffect transistor (FET), such as described in U.S. Pat. No. 7,507,675 toZuilhof et al., titled “Device Manufacturing Method and Device,” whichis incorporated herein by reference. A sensor can include anano-cantilever device, such as described in U.S. Pat. No. 7,612,424 toEspinosa and Ke, titled “Nanoelectromechanical Bistable CantileverDevice,” which is incorporated herein by reference.

In an aspect, computing component 880 includes circuitry configured toactuate at least one of first initiator 860 or second initiator 870 inresponse to input from at least one sensor 890. For example, thecomputing component can include circuitry configured to actuate at leastone of the first initiator or the second initiator in response to inputfrom an accelerometer measuring velocity of the device as it approachesa tissue target and from a proximity sensor measuring proximity of thedevice to the tissue target. For example, the computing component caninclude circuitry configured to actuate the first initiator just priorto contact with a tissue surface, as measured by a proximity sensor, andcircuitry configured to actuate the second initiator just after piercingthe tissue surface, as measured by a pressure sensor.

With reference to FIG. 9, shown is a schematic of a penetrating system.Penetrating system 900 includes penetrating device 910 and computingdevice 920. Penetrating device 910 includes penetrating portion 930,connector portion 940, fluid reservoir portion 950, first initiator 960,and second initiator 970. Penetrating portion 930 further includes aplurality of pores 932 and penetrating edge 934. Penetrating device 910is operably coupled to computing device 920 through either a wiredcommunications link 922 or a wireless communications link 924 throughtransmission unit 926. Computing device 920 of penetrating system 900includes a processor and circuitry 980 including circuitry 990configured to controllably actuate at least one of the first initiator960 or the second initiator 970. For example, computing device 920 caninclude circuitry configured to send a signal to a release mechanism,e.g., a release mechanism associated with a spring, to actuate at leastone of the first initiator 960 or the second initiator 970. For example,computing device 920 can include circuitry configured to send a signalto turn on or off a small motor associated with first initiator 960 orsecond initiator 970.

FIG. 10 illustrates further aspects of penetrating system 900 includingpenetrating device 910 operably coupled to computing device 920. FIG. 10shows a schematic of a longitudinal cross-section through penetratingdevice 910. Penetrating device 910 of penetrating system 900 includes afirst hollow cylinder 1000 having a first end 1002 and a second end1004, the first hollow cylinder 1000 including a plurality of pores 932.Penetrating device 910 of penetrating system 900 further includes asecond hollow cylinder 1006 having a first end 1008 and a second end1010, the second hollow cylinder 1006 disposed within the first hollowcylinder 1000 and substantially coaxial to the first hollow cylinder1000. Penetrating device 910 of penetrating system 900 further includesa substantially ring-shaped end piece 1012 having an outer edge 1014 andan inner edge 1016, the outer edge 1014 of substantially ring-shaped endpiece 1012 secured to the first end 1002 of the first hollow cylinder1000 and the inner edge 1016 of the substantially ring-shaped end piece1012 secured to the first end 1008 of the second hollow cylinder 1006,wherein the first hollow cylinder 1000 and the second hollow cylinder1006 and the substantially ring-shaped end piece 1012 form penetratingedge 934. Penetrating device 910 of penetrating system 900 furtherincludes an internal fluid conduit 1018 defined by a space between thefirst hollow cylinder 1000 and the substantially coaxial second hollowcylinder 1006, the internal fluid conduit 1018 in fluid communicationwith the plurality of pores 932 along the length of the first hollowcylinder 1000. Penetrating device 910 of penetrating system 900 includesa connector portion 940 with a first end 1020 and a second end 1022, theconnector portion 940 disposed over and coaxial to a region 1024 of thesecond hollow cylinder 1006 proximal to the second end 1010 of thesecond hollow cylinder 1006, the first end 1020 of the connector portion940 attached proximal to the second end 1004 of the first hollowcylinder 1000, the connector portion 940 in fluid communication with theinternal fluid conduit 1018. Penetrating device 910 of penetratingsystem 900 further includes a lumen 1026 defined by the second hollowcylinder 1006, the lumen 1026 having a first end 1028 and a second end1030, the first end 1028 of the lumen 1026 in fluid communication withthe penetrating edge 934. Penetrating device 910 of penetrating system900 includes a first fluid reservoir portion 1032 and second fluidreservoir portion 1034. A first fluid reservoir portion 1032 for holdinga first fluid composition is associated with the second end 1022 ofconnector portion 940 and is in fluid communication with the connectorportion 940 and the internal fluid conduit 1018. A second fluidreservoir portion 1034 is associated with the second end 1010 of thesecond hollow cylinder 1006, the second fluid reservoir portion 1034 influid communication with the lumen 1026 defined by the second hollowcylinder 1006. Penetrating device 910 of penetrating system 900 includesa first initiator 960 configured to induce flow of the first fluidcomposition from the first fluid reservoir portion 1032, through theinternal fluid conduit 1018, and out at least one of the plurality ofpores 932. Penetrating device 910 of penetrating system 900 includes asecond initiator 970 configured to induce flow into or out of the secondfluid reservoir 1034, through the lumen 1026 defined by the secondhollow cylinder 1006.

In an aspect, the first hollow cylinder 1000 is formed from stainlesssteel. In an aspect, the first hollow cylinder 1000 is formed from atleast one of metal, alloy, plastic, glass, polymer, or ceramic. In anaspect, the first hollow cylinder 1000 is formed from a porous material.In an aspect, the first hollow cylinder 1000 is formed from at least oneof sintered metal particulate, glass particulate, or ceramicparticulate. In an aspect, each of the plurality of pores 932 ismachined into the first hollow cylinder 1000. In an aspect, each of theplurality of pores 932 is substantially perpendicular to a central axisof the first hollow cylinder 1000. Further non-limiting aspects of afirst hollow cylinder have been described above herein.

In an aspect, the second hollow cylinder 1006 is formed from stainlesssteel. In an aspect, the second hollow cylinder 1006 is formed from atleast one of metal, alloy, plastic, glass, polymer, or ceramic. In anaspect, the substantially ring-shaped end piece 1012 is formed from atleast one of stainless steel, metal, alloy, plastic, glass, polymer, orceramic. In an aspect, the second hollow cylinder 1006 and thesubstantially ring-shaped end piece 1012 are substantially non-porous.Further non-limiting aspects of a second hollow cylinder and/or asubstantially ring-shaped end piece have been described above herein.

In an aspect, the penetrating edge 934 includes a sharp piercing edge.In an aspect, the penetrating edge 934 includes a sharp beveled edge. Inan aspect, penetrating edge 934 includes at least one sharp edge able topierce a material. In an aspect, the penetrating edge 934 includes atleast one sharp edge able to pierce metal, wood, concrete, plastic,polymer, fiberglass, resin, acrylic, latex, rubber, paper, or fabric. Inan aspect, the penetrating edge 934 includes at least one sharp edgeable to pierce plant material. In an aspect, the penetrating edge 934includes at least one sharp edge able to pierce a body tissue of ananimal. In an aspect, the penetrating edge 934 includes at least onesharp edge able to pierce skin, endothelium, muscle, adipose, bone,cartilage, eye tissue, neural tissue, or internal organ tissue.

Penetrating device 910 includes connector portion 940 associated withfirst fluid reservoir portion 1032. In an aspect, connector portion 940is directly secured to a portion of first fluid reservoir portion 1032.In an aspect, the first fluid reservoir portion 1032 is attached to thesecond end 1022 of the connector portion 1032. For example, a first endof first fluid reservoir portion 1032 can be secured, e.g., glued orfused, to the second end 1022 of connector portion 940. In an aspect,the connector portion 940 includes a fitting. For example, connectorportion 940 can include an internal diameter sized to fit into or over afirst end of the first fluid reservoir portion. In an aspect, theconnector portion 940 includes a slip-tip fitting. In an aspect, theconnector portion 940 includes a lock fitting. In an aspect, the lockfitting includes a screw fitting. In an aspect, the lock fittingincludes a Luer lock fitting.

Penetrating device 910 further includes second fluid reservoir portion1034 associated with the second end 1010 of second hollow cylinder 1006.In an aspect, the second fluid reservoir portion 1034 is attached to thesecond end 1010 of the second hollow cylinder 1006. For example, a firstend of second fluid reservoir portion 1034 can be secured, e.g., glued,fused, or welded, to the second end 1010 of second hollow cylinder 1006.

In an aspect, the first fluid reservoir portion 1032 is in fluidcommunication with the connector portion 940 and the internal fluidconduit 1018 through a flow conduit. In an aspect, the second fluidreservoir portion 1034 is in fluid communication with the lumen 1026defined by the second hollow cylinder 1006 through a flow conduit. In anaspect, the flow conduit includes a length of tubing, e.g., surgicaltubing. See, e.g., FIGS. 6A and 6B for a non-limiting example.

In an aspect, the first fluid reservoir portion 1032 includes a firsthollow tube and the second fluid reservoir portion 1034 includes asecond hollow tube, the second hollow tube disposed within the firsthollow tube. In an aspect, the second hollow tube of the second fluidreservoir portion 1034 is substantially coaxial to the first hollow tubeof the first fluid reservoir portion 1032. In an aspect, the first fluidreservoir portion 1032 and the second fluid reservoir portion 1034 areparallel to one another. For example, the first fluid reservoir portionand the second fluid reservoir portion can be parallel and concentric asshown in FIG. 10. For example, the first fluid reservoir portion and thesecond fluid reservoir portion can be parallel and not concentric, anon-limiting example of which is shown in FIG. 5.

First fluid reservoir portion 1032 is configured to hold a first fluidcomposition. In an aspect, the first fluid composition includes at leastone of an anesthetic or an analgesic. In an aspect, the first fluidcomposition of the first fluid reservoir portion includes at least oneantiseptic. In an aspect, the first fluid composition of the first fluidreservoir portion includes at least one antimicrobial agent. In anaspect, the first fluid composition of the first fluid reservoir portionincludes at least one anticoagulant. In an aspect, the first fluidcomposition of the first fluid reservoir portion includes at least oneantihemorrhagic agent. In an aspect, the first fluid composition of thefirst fluid reservoir portion includes at least one treatment agent. Inan aspect, the first fluid composition of the first fluid reservoirportion includes at least one lubricant. In an aspect, the first fluidcomposition of the first fluid reservoir portion includes at least onesealant. Non-limiting examples of anesthetics, analgesics, antiseptics,antimicrobial agents, anticoagulants, antihemorrhagic agents, treatmentagents, lubricants, and sealants have been described above herein. In anaspect, the first fluid composition is incorporated into first fluidreservoir portion 1032 at the time of manufacture. In an aspect, thefirst fluid composition is incorporated into first fluid reservoirportion 1034 at the time of use.

In an aspect, second fluid reservoir portion 1034 is configured to holda second fluid composition. In an aspect, the second fluid compositionof the second fluid reservoir portion includes at least one vaccine. Inan aspect, the second fluid composition of the second fluid reservoirportion includes at least one therapeutic agent. In an aspect, the atleast one therapeutic agent includes at least one of ananti-inflammatory agent, an antimicrobial agent, a chemotherapeuticagent, or a diabetes agent. In an aspect, the second fluid compositionof the second fluid reservoir portion includes a dye. In an aspect, thesecond fluid composition of the second fluid reservoir portion includesa wash solution.

In an aspect, the second fluid composition of the second fluid reservoirportion 1034 is configured for at least one of percutaneousadministration, intravenous administration, subcutaneous administration,intraocular administration, intraosseus administration, epiduraladministration, intraarticular administration, intraperitonealadministration, intraoral administration, or intramuscularadministration. Non-limiting examples of vaccines and therapeutic agentshave been described above herein. In an aspect, the second fluidcomposition is incorporated into the second fluid reservoir portion 1034at the time of manufacture. In an aspect, the second fluid compositionis incorporated into the second fluid reservoir portion 1034 at the timeof use.

In an aspect, the second fluid reservoir portion 1034 is configured tohold a captured sample, e.g., a biopsy sample. In an aspect, thecaptured sample includes a blood sample, bone marrow sample, tissuesample, lavage sample, or other sample captured from an animal subject.In an aspect, the captured sample includes a sample taken from a plant,e.g., a tree.

The penetrating device of system 900 includes first initiator 960 andsecond initiator 970. In an aspect, at least one of the first initiator960 or the second initiator 970 includes a plunger. In an aspect, thefirst initiator 960 includes a first plunger and the second initiator970 includes a second plunger. In an aspect the first plunger and thesecond plunger are concentric. See, e.g., FIGS. 7A and 7B. In an aspect,the first initiator 960 is a first plunger and the second initiator 970is a second plunger, the first plunger sized to fit within the firstfluid reservoir portion 1032 and to induce flow of the first fluidcomposition, the second plunger sized to fit within the second fluidreservoir portion 1034 and to induce flow into or out of the secondfluid reservoir portion 1034. In an aspect, the first initiator 960 is afirst plunger, the first plunger substantially ring-shaped and sized tofit in a space between a first hollow tube and a second hollow tubeforming the first fluid reservoir portion 1032, and wherein the secondinitiator 970 is a second plunger, the second plunger sized to fit inthe second hollow tube forming the second fluid reservoir portion 1034.Non-limiting aspects of penetrating devices including plungers have beendescribed above herein.

In an aspect, at least one of the first initiator 960 or the secondinitiator 970 includes a pump. In aspect, the system includes at leastone peristaltic pump connected to at least one of the first fluidreservoir portion or the second fluid reservoir portion. In an aspect,the system includes a first pump for actuating a thumb press of a firstplunger and a second pump for actuating a thumb press of a secondplunger. For example, the system can include a syringe pump or infusionpump into which the penetrating device including a first plunger and asecond plunger is inserted, the syringe pump operably coupled to thecomputing device of the system to control actuation of the first andsecond plungers of the penetrating device.

In an aspect, at least one of the first initiator 960 or the secondinitiator 970 includes a valve. For example, a first valve and/or asecond valve can be opened or closed to control flow of the first fluidcomposition and/or a second fluid composition. In an aspect, a firstvalve and a second valve are operably coupled and controllably actuatedby computing device 920. In an aspect, a first valve and a second valveare operably independent and independently actuated by computing device920.

In an aspect, the first initiator 960 and the second initiator 970 areoperably coupled. For example, actuation, e.g., movement, of firstinitiator 960 causes actuation of second initiator 970. In an aspect,the first initiator 960 and the second initiator 970 are operablyindependent. For example, operation of first initiator 960 isindependent of second initiator 970.

In an aspect, the computing device 920 and the penetrating device 910are operably connected through a wired communication link 922. Forexample, the computing device may be linked to the penetrating devicethrough a cable, e.g., a universal serial bus (USB) cable.

FIG. 11 shows further aspects of penetrating system 900. Penetratingsystem 900 includes penetrating device 910 and computing device 920. Inan aspect, the computing device 920 is operably coupled to thepenetrating device 910 through a wireless communication link 924mediated by transmission unit 1100.

In an aspect, the penetrating device 910 includes a transmission unit1100 including an antenna. A “transmission unit,” as used herein, can beone or more of a variety of units that are configured to send and/orreceive signals, such as signals carried as electromagnetic waves. Atransmission unit generally includes at least one antenna and associatedcircuitry. A transmission unit can include a transmitter and a receiver.A transmission unit can include volatile or non-volatile memory. Atransmission unit can include a processor and/or be operably connectedto a processor. A transmission unit can be operably connected to anenergy source, such as a battery. A transmission unit can include anenergy harvesting unit, such as a unit configured to obtain energy fromelectromagnetic waves. A transmission unit can include a transponderutilizing electromagnetic waves, for example as described in“Fundamental Operating Principles,” in Chapter 3 of the RFID Handbook:Fundamentals and Applications in Contactless Smart Cards andIdentification, Klaus Finkenzeller, John Wiley & Sons, (2003), which isincorporated herein by reference. A transmission unit can include anoscillator and encoder configured to generate a programmable pulseposition-modulated signal in the radio frequency range (see, e.g., U.S.Pat. No. 4,384,288, which is incorporated herein by reference). Atransmission unit can include a radio frequency identification device(RFID), which can be a passive RFID device, a semi-passive RFID device,or an active RFID device, depending on the embodiment (see, e.g., Chawla& Ha, “An Overview of Passive RFID,” IEEE Applications and Practice,11-17 (September 2007), which is incorporated herein by reference). Atransmission unit including an RFID device can be configured to transmitsignals in the UHF standard range. A transmission unit can include abattery-assisted passive RFID device, such as sold by Alien Technology®,Morgan Hill, Calif. A transmission unit can include an opticaltransmission unit. A transmission unit can include a hybrid backscattersystem configured to function in an RFID, IEEE 802.11x standard andBluetooth system (see, e.g., U.S. Pat. No. 7,215,976, which isincorporated herein by reference). A transmission unit can include anear field communication (NFC) device. A transmission unit can include aWireless Identification and Sensing Platform (WISP) device.

Computing device 920 of penetrating system 900 includes a microprocessorand circuitry 980. Circuitry 980 further includes circuitry 990configured to controllably actuate at least one of first initiator 960or second initiator 970. In an aspect, the computing device 920 includescircuitry 1110 configured to controllably actuate the first initiator960 and the second initiator 970 simultaneously. For example, thecomputing device can include circuitry configured to send signalssimultaneously to the first and second initiators to simultaneouslyactuate, e.g., initiate movement of, the first and second initiators.For example, flow of the first fluid composition from the first fluidreservoir portion and flow into or out of the second fluid reservoirportion can be simultaneously initiated. In an aspect, computing device920 includes circuitry 1120 configured to controllably actuate the firstinitiator 960 and the second initiator 970 sequentially. For example,the computing device can include circuitry configured to send sequentialsignals to the first and second initiators to sequentially actuate,e.g., initiate movement of, the first and second initiators. Forexample, a dosing protocol may include administering a first fluidcomposition, e.g., an analgesic such as lidocaine, as the penetratingportion is entering the skin followed by administering a second fluidcomposition, a therapeutic agent. In an aspect, computing device 920includes circuitry 1130 configured to controllably actuate at least oneof the first initiator 960 to deliver a fixed amount of the first fluidcomposition or the second initiator 970 to deliver a fixed amount of thesecond fluid composition. For example, the computing device can includea user interface, e.g., a keyboard and display, for entering dosinginformation. In an aspect, computing device 920 includes circuitry 1140configured to controllably actuate at least one of the first initiator960 to deliver the first fluid composition or the second initiator 970to deliver the second fluid composition based on time from entering aninjection site. For example, the first initiator may be actuated as thepenetrating edge of the penetrating device touches the skin surface andthe second initiator may be actuated at a subsequent time point, e.g.,milliseconds or microseconds later.

In an aspect, computing device 920 includes circuitry configured toexecute one or more instructions for controlling actuation of the firstand second initiators. In an aspect, the computing device includescircuitry configured to execute one or more instructions forcontrollably actuating at least one of the first initiator or the secondinitiator. In an aspect, the computing device includes circuitryconfigured to execute one or more instructions for controllablyactuating the first initiator and the second initiator simultaneously.In an aspect, the computing device includes circuitry configured toexecute one or more instructions for controllably actuating the firstinitiator and the second initiator sequentially. In an aspect, thecomputing device includes circuitry configured to execute one or moreinstructions for controllably actuating at least one of the firstinitiator to deliver a fixed amount of the first fluid composition orthe second initiator to deliver a fixed amount of a second fluidcomposition. In an aspect, the computing device includes circuitryconfigured to execute one or more instructions for controllablyactuating at least one of the first initiator to deliver the first fluidcomposition or the second initiator to deliver the second fluidcomposition based on time from entering an injection site.

In an aspect, the computing device includes a processor, e.g., a centralprocessing unit, for controlling one or more functions of thepenetrating device or other peripheral components, e.g., pumps. Thecomputing device further includes a system memory and a system bus thatcouples various system components including the system memory to theprocessor. The processor can include a microprocessor, a processingunit, a central processing unit (CPU), a digital signal processor (DSP),an application-specific integrated circuit (ASIC), a field programmablegate entry (FPGA), or the like, or any combinations thereof, and caninclude discrete digital or analog circuit elements or electronics, orcombinations thereof. In an aspect, the computing component includes oneor more ASICs having a plurality of pre-defined logic components. In anaspect, the computing device includes one or more FPGA having aplurality of programmable logic commands.

In an aspect, the computing device is operably coupled to one or moreinput/output components. In an aspect, the one or more input/outputcomponents include the penetrating device. In an aspect, the one or moreinput/output components include one or more pumps. In an aspect, the oneor more input/output components include one or more user interfacecomponents. Non-limiting examples of user interface components include adisplay, touchscreen, keyboard, keypad, microphone, speaker, mouse,joystick, stylus pen, dial, buttons, switches, or printer. In an aspect,the one or more input/output components are connected to the processorof the computing device through one or more user input interfaces thatare coupled to the system bus, but may be connected by other interfacesand bus structures, such as a parallel port, game port, or a universalserial bus (USB). For example, external input components or outputcomponents may be connected to the processor through a USB port. Forexample, the penetrating device may be connected to the processorthrough a USB port. The computing device may further include or becapable of connecting to a flash card memory or other portable datastorage device. The computing device may further include or be capableof connecting with a network through a network port and networkinterface, and through wireless port and corresponding wirelessinterface may be provided to facilitate communication with otherperipheral devices, for example, a smart phone, a computer, a displaymonitor, and/or a printer. For example, the computing device can includea wireless interface to facilitate wireless communication with thetransmission unit of the penetrating fluid deliver device.

In an aspect, the computing device includes image-based applicationssuch as viewers and/or toolkits (e.g., Insight Segmentation andRegistration Toolkit (ITK)). In an aspect, image segmentation or otherimage analysis algorithms may allow processing of images received fromthe at least one sensor associated with the penetrating device.

The computing device further includes a memory component. The memorycomponent can include memory chips, e.g., ROM or flash memory chips, forproviding storage of operating systems, look-up tables, referencesdatasets, and algorithms for controllably actuating the first and secondinitiators of the penetrating device. The memory component of thecomputing device may include read-only memory (ROM) and random accessmemory (RAM). A number of program modules may be stored in the ROM orRAM, including an operating system, one or more application programs,other program modules and program data.

The computing device includes computer-readable media products and mayinclude any media that can be accessed by the computing device includingboth volatile and nonvolatile media, removable and non-removable media.By way of example, and not of limitation, computer-readable media mayinclude non-transitory signal-bearing media. Non-limiting examples ofnon-transitory signal-bearing media include a recordable type mediumsuch as magnetic tape, a hard disk drive, digital tape, computer memory,or the like, as well as transmission type medium such as a digitaland/or analog communication medium (e.g., fiber optic cable, waveguide,wired communications link, wireless communication link). Furthernon-limiting examples of signal-bearing media include, but are notlimited to, flash memory, magnetic tape, MINIDISC, non-volatile memorycard, EEPROM, optical disk, optical storage, RAM, ROM, system memory,web server, cloud, or the like. By way of example, and not oflimitation, computer-readable media may include computer storage media,e.g., magnetic tape, magnetic disk storage, optical disk storage, memorycards, flash memory cards, electrically erasable programmable read-onlymemory (EEPROM), solid state RAM, and solid state ROM or any othermedium which can be used to store the desired information and which canbe accessed by the computing component. By way of further example, andnot of limitation, computer-readable media may include a communicationmedia, e.g., wired media, such as a wired network and a direct-wiredconnection, and wireless media such as acoustic, RF, optical, andinfrared media.

In an aspect, system 900 further includes at least one sensor. In anaspect, the at least one sensor is a standalone sensor that monitors theuse of penetrating device 910, e.g., an image capture device operablycoupled to computing device 920. In an aspect, the at least one sensoris incorporated into penetrating device 910, e.g., sensor 1150. In anaspect, at least one sensor 1150 is operably coupled to computing device920. In an aspect, at least one sensor 1150 is operably coupled tocomputing device 920 through a wireless communications link 924 viatransmission unit 1100. In an aspect, at least one sensor 1150 isoperably coupled to computing device 920 through a wired communicationslink. In an aspect, computing device 920 includes circuitry configuredto actuate at least one of the first initiator 960 or the secondinitiator 970 in response to input from the at least one sensor 1150.

In an aspect, at least one sensor 1150 includes at least oneaccelerometer. For example, the accelerometer can include one or morepiezoelectric, piezoresistive, or capacitive components for convertingmechanical motion into an electrical signal. In an aspect, theaccelerometer is used in combination with computing device 920 for aninertial navigation system to calculate the position, orientation, andvelocity of the penetrating device. In an aspect, at least one sensor1150 includes at least one proximity sensor. In an aspect, the at leastone sensor 1150 includes at least one clock. In an aspect, at least onesensor 1150 includes at least one timer. In an aspect, the at least onesensor 1150 includes at least one pressure sensor. For example, apressure sensor can be used to detect when the penetrating portion ofthe penetrating device comes in contact with a surface, e.g., a tissuesurface. For example, the at least one pressure sensor can include apiezoresistive strain gauge. In an aspect, the at least one sensor 1150includes at least one temperature sensor. For example, a temperaturesensor can be used to detect when the penetrating portion of thepenetrating device comes near or in contact with a heated surface, e.g.,the surface of the skin. In an aspect, the at least one sensor 1150includes at least one chemical sensor. Non-limiting examples of sensorshave been described above herein.

FIG. 12 illustrates aspects of a penetrating system including at leastone pump for inducing flow of the first and/or second fluid compositionthrough the penetrating device. System 1200 includes penetrating device1210 and computing device 1220. Penetrating device 1210 includespenetrating portion 1230 and connector portion 1240. Penetrating portion1230 includes penetrating edge 1232, first hollow cylinder 1234, and aplurality of pores 1236. Internally, penetrating device 1210 includes asecond hollow cylinder disposed within first hollow cylinder 1234, asubstantially ring-shaped end piece attached to the first ends of thefirst and second hollow cylinders, an internal fluid conduit defined bythe space between first hollow cylinder 1234 and the second hollowcylinder, and a lumen defined by the second hollow cylinder. Connectorportion 1240 includes lid portion 1250. Lid portion 1250 includes firstinlet 1252 in fluid communication with connector portion 1240, theinternal flow conduit defined by the space between first hollow cylinder1234 and the second hollow cylinder disposed within first hollowcylinder 1234, and at least one of the plurality of pores 1236. Firstinlet 1252 includes tubing 1254 attached to first fluid reservoirportion 1260 through first pump 1270. First pump 1270 controllablyinduces flow of a first fluid composition from first fluid reservoirportion 1260 through tubing 1254, inlet 1252, connector portion 1240,the internal flow conduit, and out at least one of the plurality ofpores 1236. Lid portion 1250 further includes second inlet 1256 in fluidcommunication with the lumen defined by the second hollow cylinder.Second inlet 1256 includes tubing 1258 attached to second fluidreservoir portion 1280 through second pump 1290. Second pump 1290controllably induces flow into or out of second fluid reservoir portion1280 through a path defined by tubing 1258, inlet 1256, the lumendefined by the second hollow cylinder, and penetrating edge 1232. In anaspect first pump 1270 and second pump 1290 are separate pumps. In anaspect, first pump 1270 is an infusion pump and second pump 1290 is anaspiration pump. In an aspect first pump 1270 and second pump 1290 arepart of the same pump system, e.g., a dual head or multichannelperistaltic pump. Non-limiting aspects of pumps have been describedabove herein. In an aspect, computing device 1220 is incorporated into adual head or multichannel peristaltic pump including first pump 1270 andsecond pump 1290. In an aspect, first pump 1270 and/or second pump 1290are situated upstream of first fluid reservoir portion 1260 and/orsecond fluid reservoir portion 1280, respectively. For example, thefirst and/or second pump can include a pump that pushes fluid out of thefirst and/or second fluid reservoir portion.

First pump 1270 and second pump 1290 are operably coupled to computingdevice 1220 through communication link 1295. Computing device 1220includes circuitry configured to controllably actuate at least one offirst pump 1270 or second pump 1290. In an aspect, computing device 1220includes circuitry configured to actuate first pump 1270 and second pump1290 simultaneously. In an aspect, computing device 1220 includescircuitry configured to actuate first pump 1270 and second pump 1290sequentially. In an aspect, computing device 1220 includes circuitryconfigured to controllably actuate at least one of first pump 1270 todeliver a fixed amount of the first fluid composition or second pump1290 to deliver a fixed amount of a second fluid composition. In anaspect, computing device 1220 includes circuitry configured tocontrollably actuate at least one of first pump 1270 to deliver thefirst fluid composition or second pump 1290 to deliver a second fluidcomposition based on time from entering an injection site.

In an aspect, the penetrating system further includes a needle actuationmechanism including at least one of a deployment mode and a retractionmode. For example, the penetrating device of the system can include aneedle actuation mechanism for deploying the penetrating portion of thedevice just prior to piercing a surface and/or for retracting thepenetrating portion following delivery of the second fluid compositionor aspiration of a captured sample. In an aspect, the needle actuationmechanism includes a spring-loaded mechanism with tension and manualrelease. See, e.g., U.S. Pat. No. 7,744,582 to Sadowski et al. titled“Needle Assisted Jet Injector,” which is incorporated herein byreference. In an aspect, the needle actuation mechanism includes use ofa shape memory alloy. For example, the needle actuation mechanism caninclude a penetrating portion formed from shape memory alloy nickeltitanium, which by changing shape is both deployable and retractable.See, e.g., U.S. Pat. No. 6,605,067 to Larsen titled “Injection Needle,”which is incorporated herein by reference. In an aspect, the needleactuation mechanism is manually activated. For example, a coiled springassociated with deploying the penetrating portion can be actuated bypushing a button or flipping a switch that mechanically releases thespring-loaded penetrating portion. In an aspect, the needle actuationmechanism includes an ejection force controlled by electronics. See,e.g., U.S. Patent Application No. 2007/0197968 to Pongpairochana et al.titled “Hand-Held Electronically Controlled Injection Device forInjecting Liquid Medications,” which is incorporated herein byreference. For example, the penetrating portion of the penetratingdevice can be associated with a piston that electronically ejects and/orretracts the penetrating portion. In an aspect, the computing device ofthe system includes circuitry configured to control the needle actuationmechanism. In an aspect, the computing device of the system includescircuitry configured to control speed of needle deployment. In anaspect, the needle actuation mechanism can include active refraction,e.g., wherein when the second initiator, e.g., plunger, is pressed toexpel contents of the second reservoir portion, the base of the plungerattaches to the needle. Pulling back on the plunger causes the needle toretract into the barrel of the syringe. In an aspect, the needleactuation mechanism includes passive retraction. For example, contactingthe plunger to the base of the syringe at the completion of injectiontriggers a spring mechanism which automatically retracts the penetratingneedle portion. See, e.g., U.S. Pat. No. 6,572,584 to Shaw et al titled“Retractable Syringe with Reduce Retraction Force,” which isincorporated herein by reference. For example, the penetrating portioncan be fully fused to the syringe and spring-loaded such that thepenetrating portion retracts into the barrel of the syringe when theplunger is completely depressed after the injection is given. In anaspect, the force associated with deploying the penetrating portion issufficient to expel the first fluid composition from the first fluidreservoir portion and out at least one of the plurality of pores.

FIGS. 13A and 13B illustrates aspects of a penetrating device includinga needle actuation mechanism. FIG. 13A is a longitudinal cross-sectionthrough a portion of penetrating device 1300 and shows the penetratingportion of the device in a refracted state. Penetrating device 1300includes first hollow cylinder 1310 including a plurality of pores 1315.Penetrating device 1300 further includes second hollow cylinder 1320disposed within and substantially coaxial to first hollow cylinder 1310.First hollow cylinder 1310 and second hollow cylinder 1320 are attachedto substantially ring-shaped end piece 1325 to form penetrating edge1330. Penetrating device 1300 further includes first fluid reservoirportion 1335 including first extension 1340 and stop portion 1345. Firsthollow cylinder 1310 is disposed within first extension 1340 of firstfluid reservoir portion 1335. Penetrating device 1300 includes secondfluid reservoir portion 1350 including second extension 1355. In therefracted state shown in FIG. 13A, second extension 1355 is disposedwithin the space between first hollow cylinder 1310 and second hollowcylinder 1320. Penetrating device 1300 further includes spring 1360. InFIG. 13A, spring 1360 is in a compressed form and first hollow cylinder1310 and second hollow cylinder 1320 are completely refracted withinfirst extension 1340. FIG. 13B is a longitudinal cross-section through aportion of penetrating device 1300 and shows the penetrating portion ofthe device in a deployed state. Spring 1360 has been actuated and is ina relaxed state. The penetrating portion including first hollow cylinder1310 and second hollow cylinder 1320 are shown deployed beyond the endof first extension 1340. Stop portion 1345 limits the degree to whichthe penetrating portion can be deployed.

In an aspect, the computing device of the system includes circuitryconfigured to actuate a needle actuation mechanism in response to inputfrom the at least one sensor. For example, the computing device caninclude circuitry configured to actuate the needle actuation mechanismto deploy the penetrating portion in response to input from a proximitysensor indicating proximity of the target tissue. For example, thecomputing device can include circuitry configured to actuate the needleactuation mechanism to retract the penetrating portion in response toinput from a pressure sensor indicating cessation of pressure on asecond initiator, e.g., a plunger, at completion of injecting a vaccineand/or therapeutic agent.

With reference to FIGS. 14A and 14B, shown are aspects of a penetratingdevice. FIG. 14A shows a schematic of an external view of penetratingdevice 1400. Penetrating device 1400 includes penetrating portion 1410and connector portion 1420. Penetrating portion 1410 includespenetrating edge 1412 and a plurality of pores 1414. FIG. 14B shows aschematic of a longitudinal cross-section through penetrating device1400. Penetrating device 1400 includes a first hollow cylinder 1430having a first end 1432 and a second end 1434, the first hollow cylinder1430 including a plurality of pores 1414, the second end 1434 of thefirst hollow cylinder 1430 having a connector portion 1420. Penetratingdevice 1400 includes a second hollow cylinder 1436 having a first end1438 and a second end 1440, the second hollow cylinder 1436 disposedwithin the first hollow cylinder 1430 and substantially coaxial to thefirst hollow cylinder 1430. Penetrating device 1400 includes asubstantially ring-shaped first end piece 1442 having an outer edge 1444and an inner edge 1446, the outer edge 1444 of the substantiallyring-shaped first end piece 1442 secured to the first end 1432 of thefirst hollow cylinder 1430 and the inner edge 1446 of the substantiallyring-shaped first end piece 1442 secured to the first end 1438 of thesecond hollow cylinder 1436, wherein the first hollow cylinder 1430, thesecond hollow cylinder 1436, and the substantially ring-shaped first endpiece 1442 form a penetrating edge 1412. Penetrating device 1400includes a substantially ring-shaped second end piece 1448 having anouter edge 1450 and an inner edge 1452, the outer edge 1450 of thesubstantially ring-shaped second end piece 1448 adjacent to a portion ofthe first hollow cylinder 1430 proximal to the second end 1434 of thefirst hollow cylinder 1430 and the inner edge 1452 of the substantiallyring-shaped second end piece 1448 adjacent to a portion of the secondhollow cylinder 1436 proximal to the second end 1440 of the secondhollow cylinder 1436, the substantially ring-shaped second end piece1448 forming a deformable barrier. Penetrating device 1400 includes afluid reservoir portion 1454 for holding a fluid composition, the fluidreservoir portion 1454 defined by the first hollow cylinder 1430, thesecond hollow cylinder 1436, the substantially ring-shaped first endpiece 1442, and the substantially ring-shaped second end piece 1448, thefluid reservoir portion 1454 in fluid communication with the pluralityof pores 1414. Penetrating device 1400 includes a lumen 1456 defined bythe second hollow cylinder 1436, the lumen 1456 having a first end 1458and a second end 1460, the first end 1458 of the lumen 1456 in fluidcommunication with the penetrating edge 1412.

Penetrating device 1400 includes a first hollow cylinder 1430. In anaspect, the first hollow cylinder 1430 is formed from stainless steel.In an aspect, the first hollow cylinder 1430 is formed from at least oneof metal, alloy, plastic, glass, polymer, or ceramic. In an aspect, thefirst hollow cylinder 1430 is formed from a porous material. In anaspect, the first hollow cylinder 1430 is formed from at least one ofsintered metal particulate, glass particulate, or ceramic particulate.Non-limiting aspects of forming a first hollow cylinder have beendescribed above herein.

First hollow cylinder 1430 includes a plurality of pores 1414. In anaspect each of the plurality of pores is substantially perpendicular toa central axis of the first hollow cylinder. In an aspect, each of theplurality of pores is oriented at 90 degrees relative to the centralaxis of the first hollow cylinder. In an aspect, each of the pluralityof pores is oriented at 45 degrees relative to the central axis of thefirst hollow cylinder. In an aspect, each of the plurality of pores isoriented at about 90 degrees to about 20 degrees relative to the centralaxis of the first hollow cylinder.

For example, each of the plurality of pores can be oriented at 90degrees, 85 degrees, 80 degrees, 75 degrees, 70 degrees, 65 degrees, 60degrees, 55 degrees, 50 degrees, 45 degrees, 40 degrees, 35 degrees, 30degrees, 25 degrees, or 20 degrees relative to the central axis of thefirst hollow cylinder. In an aspect, each of the plurality of pores isat substantially the same angle relative to the central axis of thefirst hollow cylinder. For example, each of the plurality of pores canbe machined at a substantially 90 degrees relative to the central axisof the first hollow cylinder 1430. In an aspect, one or more of theplurality of pores are at different angles relative to the central axisof the first hollow cylinder 1430. For example, a first hollow cylindermanufactured from a porous material, e.g., porous ceramic, may havepores angled at varied degrees relative to the central axis of the firsthollow cylinder.

In an aspect, the plurality of pores includes at least two pores. In anaspect, the plurality of pores includes 2 pores to about 100 pores. Forexample, the plurality of pores can include 2 pores, 3 pores, 4 pores, 5pores, 6 pores, 7 pores, 8 pores, 9 pores, 10 pores, 15 pores, 20 pores,25 pores, 30 pores, 35 pores, 40 pores, 45 pores, 50 pores, 55 pores, 60pores, 65 pores, 70 pores, 75 pores, 80 pores, 85 pores, 90 pores, 95pores, or 100 pores. In an aspect, the plurality of pores includes about100 pores to about 100,000 pores. In an aspect, the plurality of poresincludes over 100,000 pores. In an aspect, the number of pores isdependent upon the manufacturing process. For example, forming theplurality of pores by manufacturing first hollow cylinder 1430 from aporous material may include substantially more pores than forming theplurality of pores by machining the pores into the first hollowcylinder.

In an aspect, the plurality of pores is distributed over the entirety ofthe first hollow cylinder 1430. In an aspect, the plurality of pores isdistributed over a portion of the first hollow cylinder 1430. Forexample, the plurality of pores can be distributed towards the first endof the first hollow cylinder. For example, the plurality of pores can bedistributed towards the second end of the first hollow cylinder. Forexample, the plurality of pores can be concentrated to side of the firsthollow cylinder.

In an aspect, the plurality of pores includes pores of at least onefirst size and pores of at least one second size. The plurality of poresof the first size may be distributed in a first location along thelength of the first hollow cylinder and the plurality of pores of thesecond size may be distributed in a second location along the length ofthe first hollow cylinder. In an aspect, the plurality of pores includeat least one first set of pores at a first angle relative to the centralaxis of the first hollow cylinder and at least one second set of poresat a second angle relative to the central axis of the first hollowcylinder. The plurality of pores at the first angle may be distributedin a first location along the length of the first hollow cylinder andthe plurality of pores at the second angle may be distributed in asecond location along the length of the first hollow cylinder.

In an aspect, each of the plurality of pores is machined into the firsthollow cylinder. In an aspect, each of the plurality of pores ismachined into the first hollow cylinder with a drill. In an aspect, eachof the plurality of pores is machined into the first hollow cylinderusing pins and/or needles. For example, the plurality of pores can bemachined into the first hollow cylinder using a rotary pinnedperforation roller with either cold or hot pins. In an aspect, each ofthe plurality of pores is machined into the first hollow cylinder with alaser. Non-limiting examples of lasers for laser cutting and/or boringinclude CO₂ lasers, neodymium (Nd) lasers, or neodymiumyttrium-aluminum-garnet (Nd-YAG) lasers. In an aspect, each of theplurality of pores is machined into the first hollow cylinder using awaterjet cutter. For example, each of the plurality of pores can bemachined into the first hollow cylinder using a waterjet cutter with orwithout an added abrasive, e.g., garnet or aluminum oxide.

First hollow cylinder 1430 further includes connector portion 1420. Inan aspect, the connector portion 1420 of the second end 1434 of thefirst hollow cylinder 1430 is configured to connect to a second fluidreservoir portion. In an aspect, the second fluid reservoir portionincludes a syringe. For example, the connector portion can be configuredto connect to a 1 milliliter syringe. In an aspect, the syringe caninclude any of a number of standard syringes used for injection ofvaccines and/or therapeutic agents. In an aspect, the syringe caninclude any of a number of standard syringes used for general blooddraw. In an aspect, the syringe can include any of a number of standardsyringes used for general aspiration. In an aspect, the syringe caninclude any of a number of standard syringes used for biopsy. Syringessuch as those above are available from commercial sources, e.g., fromBecton, Dickinson and Company, Franklin Lakes, N.J. or Covidien,Mansfield, Mass. In an aspect, the syringe can include any of a varietyof sizes including, but not limited to, 0.05 ml, 0.1 ml, 0.5 ml, 1.0 ml,3 ml, 5 ml, 6 ml, 10 ml, 20 ml, 35 ml, 50 ml, or 60 ml. In an aspect,the syringe is manufactured from plastic. In an aspect, the syringe ismanufactured from glass. In an aspect, the syringe is intended forsingle use. In an aspect, the syringe includes any of a number ofstandard syringes, auto-disable syringes, or retractable syringespre-qualified for use by the World Health Organization. See, e.g.,Product List at WHO website accessed Dec. 10, 2013 at the followingaddresshttp://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=37,which is incorporated herein by reference.

In an aspect, the connector portion 1420 of the second end 1434 of thefirst hollow cylinder 1430 is configured to connect to an aspirationdevice. In an aspect, the connector portion 1420 of the second end 1434of the first hollow cylinder 1430 is configured to connect to a biopsydevice. In an aspect, the connector portion 1420 of the second end 1434of the first hollow cylinder 1430 is configured to connect to anevacuated tube, e.g., a BD Vacutainer® Blood Collection Tube fromBecton, Dickinson and Company.

In an aspect, the connector portion 1420 of the second end 1434 of thefirst hollow cylinder 1430 includes a fitting sized for attachment to asyringe. In an aspect, the connector portion 1420 of the second end 1434of the first hollow cylinder 1430 includes a slip-tip fitting. In anaspect, the connector portion 1420 of the second end 1434 of the firsthollow cylinder 1430 includes a lock fitting. In an aspect, theconnector portion 1420 of the second end 1434 of the first hollowcylinder 1430 includes a Luer lock fitting. In an aspect, the connectorportion 1420 of the second end 1434 of the first hollow cylinder 1430includes a screw fitting.

Penetrating device 1400 includes second hollow cylinder 1436. In anaspect, the second hollow cylinder 1436 is formed from stainless steel.In an aspect, the second hollow cylinder 1436 is formed form at leastone of metal, alloy, plastic, glass, polymer, or ceramic. Non-limitingaspects of forming a second hollow cylinder are described above herein.

Penetrating device 1400 includes substantially ring-shaped first endpiece 1442. In an aspect, the substantially ring-shaped first end piece1442 is formed from at least one of stainless steel, metal, alloy,plastic, glass, polymer, or ceramic. In an aspect, the second hollowcylinder 1436 and the substantially ring-shaped first end piece 1442 aresubstantially non-porous. For example, the fluid composition in thefluid reservoir portion is able to flow through the plurality of poresin the first hollow cylinder but not through the second hollow cylinderor the substantially ring-shaped first end piece.

Penetrating device 1400 further includes a substantially ring-shapedsecond end piece 1448 which forms a deformable barrier. In an aspect,the substantially ring-shaped second end piece is formed from adeformable material. FIGS. 15A and 15B illustrates aspects of apenetrating device including a substantially ring-shaped second endpiece formed from a deformable material. FIG. 15A is a schematic of alongitudinal cross-section through penetrating device 1500. Penetratingdevice 1500 includes a first hollow cylinder 1430 having a first end1432 and a second end 1434, the first hollow cylinder 1430 including aplurality of pores 1414, the second end 1434 of the first hollowcylinder 1430 having a connector portion 1420; a second hollow cylinder1436 having a first end 1438 and a second end 1440, the second hollowcylinder 1436 disposed within the first hollow cylinder 1430 andsubstantially coaxial to the first hollow cylinder 1430; a substantiallyring-shaped first end piece 1442 having an outer edge 1444 and an inneredge 1446, the outer edge 1444 of the substantially ring-shaped firstend piece 1442 secured to the first end 1432 of the first hollowcylinder 1430 and the inner edge 1446 of the substantially ring-shapedfirst end piece 1442 secured to the first end 1438 of the second hollowcylinder 1436, wherein the first hollow cylinder 1430, the second hollowcylinder 1436, and the substantially ring-shaped first end piece 1442form a penetrating edge 1412; a substantially ring-shaped second endpiece 1510 having an outer edge 1520 and an inner edge 1530, the outeredge 1520 of the substantially ring-shaped second end piece 1510 securedto a portion of the first hollow cylinder 1430 proximal to the secondend 1434 of the first hollow cylinder 1430 and the inner edge 1530 ofthe substantially ring-shaped second end piece 1510 secured proximal tothe second end 1440 of the second hollow cylinder 1436, thesubstantially ring-shaped second end piece 1510 formed from a deformablematerial; a fluid reservoir portion 1540 for holding a fluid composition(shown as stippling), the fluid reservoir portion 1540 defined by thefirst hollow cylinder 1430, the second hollow cylinder 1436, thesubstantially ring-shaped first end piece 1442, and the substantiallyring-shaped second end piece 1510, the fluid reservoir portion 1540 influid communication with the plurality of pores 1414; and a lumen 1456defined by the second hollow cylinder 1436, lumen 1456 having a firstend 1458 and a second end 1460, the first end 1458 of lumen 1456 influid communication with the penetrating edge 1412.

FIG. 15B is a schematic of a longitudinal cross-section of penetratingdevice 1500 in the presence of a pressure 1550. In an aspect, pressure1550 causes the deformable material of the substantially ring-shapedsecond end piece 1510 to deform. In an aspect, deformation of thedeformable material of the substantially ring-shaped second end piece1510 induces flow of the fluid composition (shown as stippling) from thefluid reservoir portion 1540 out at least one of the plurality of pores1414. In an aspect, the deformation of the deformable material of thesubstantially ring-shaped second end piece is reversible, e.g.,reversibly altering the shape of the substantially ring-shaped secondend piece. In an aspect, the deformation of the deformable material ofthe substantially ring-shaped second end piece is irreversible, e.g.,irreversibly altering the shape of the substantially ring-shaped secondend piece.

In an aspect, the substantially ring-shaped second end piece 1510 isformed from a thin barrier of deformable material. For example, thesubstantially ring-shaped second end piece can be formed from a thinbarrier of reversibly deformable material, e.g., an elastomer. Forexample, the substantially ring-shaped second end piece can be formedfrom a thin barrier of irreversibly deformable material, e.g., a thinbarrier of aluminum. In an aspect, the substantially ring-shaped secondend piece 1510 is formed from a deformable polymer. For example, thesubstantially ring-shaped second end piece can be formed from adeformable plastic or rubber. In an aspect, the substantiallyring-shaped second end piece 1510 is formed from deformable plastic. Forexample, the substantially ring-shaped second end piece can be formedfrom a thin piece of molded low density polyethylene. Non-limitingexamples of plastics include polyethylene terephthalate, polyethylene,polyvinyl chloride, polyvinylidene chloride, polypropylene, polystyrene,nylons, polycarbonate, or polyurethanes. In an aspect, the substantiallyring-shaped second end piece 1510 is formed from a deformable metal. Forexample, the substantially ring-shaped second end piece can be formedfrom a thin sheet of aluminum. In an aspect, the deformable metalincludes a ductile metal, e.g., copper, silver, or gold. In an aspect,the substantially ring-shaped second end piece is formed from a shapememory metal, e.g., nickel titanium alloy.

In an aspect, the substantially ring-shaped second end piece is formedfrom a rigid, low-friction material. FIGS. 16A and 16B illustrateaspects of a penetrating device including a substantially ring-shapedsecond end piece formed from a rigid, low-friction material. FIG. 16A isa schematic of a longitudinal cross-section through penetrating device1600. Penetrating device 1600 includes a first hollow cylinder 1430having a first end 1432 and a second end 1434, the first hollow cylinder1430 includes a plurality of pores 1414, the second end 1434 of thefirst hollow cylinder 1430 having a connector portion 1420; a secondhollow cylinder 1436 having a first end 1438 and a second end 1440, thesecond hollow cylinder 1436 disposed within the first hollow cylinder1430 and substantially coaxial to the first hollow cylinder 1430; asubstantially ring-shaped first end piece 1442 having an outer edge 1444and an inner edge 1446, the outer edge 1444 of the substantiallyring-shaped first end piece 1442 secured to the first end 1432 of thefirst hollow cylinder 1430 and the inner edge 1446 of the substantiallyring-shaped first end piece 1442 secured to the first end 1438 of thesecond hollow cylinder 1436, wherein the first hollow cylinder 1430, thesecond hollow cylinder 1436, and the substantially ring-shaped first endpiece 1442 form a penetrating edge 1412; a substantially ring-shapedsecond end piece 1610 having an outer edge 1620 and an inner edge 1630,the outer edge 1620 of the substantially ring-shaped second end piece1610 adjacent to a portion of the first hollow cylinder 1430 proximal tothe second end 1434 of the first hollow cylinder 1430 and the inner edge1630 of the substantially ring-shaped second end piece 1610 adjacent toa portion of the second hollow cylinder 1436 proximal to the second end1440 of the second hollow cylinder 1436, the substantially ring-shapedsecond end piece 1610 forming a movable barrier; a fluid reservoirportion 1640 for holding a fluid composition (shown as stippling), thefluid reservoir portion 1640 defined by the first hollow cylinder 1430,the second hollow cylinder 1436, the substantially ring-shaped first endpiece 1442, and the substantially ring-shaped second end piece 1610, thefluid reservoir portion 1640 in fluid communication with the pluralityof pores 1414; and a lumen 1456 defined by the second hollow cylinder1436, the lumen 1456 having a first end 1458 and a second end 1460, thefirst end 1458 of the lumen 1456 in fluid communication with thepenetrating edge 1412.

FIG. 16B is a schematic of a longitudinal cross-section of penetratingdevice 1600 in the presence of a pressure 1650. In an aspect, pressure1650 causes the substantially ring-shaped second end piece 1610 formedfrom a rigid, low friction material to move. In an aspect, movement ofthe substantially ring-shaped second end piece 1610 formed from therigid, low friction material in the fluid reservoir portion 1640 inducesflow of the fluid composition (shown as stippling) from the fluidreservoir portion 1640 out at least one of the plurality of pores 1414.In an aspect, the substantially ring-shaped second end piece 1610 is atleast partially formed from a rigid, low-friction material. In anaspect, the rigid, low-friction material includes silicone.

In an aspect, the substantially ring-shaped second end piece forms adeformable barrier. In an aspect, deforming the deformable barrierinduces flow of the fluid composition from the fluid reservoir portionand out at least one of the plurality of pores. In an aspect, thedeformable barrier formed by the substantially ring-shaped second endpiece is deformable in response to pressure. In an aspect, thedeformable barrier formed by the substantially ring-shaped second endpiece is deformable in response to manually applied pressure. In anaspect, the deformable barrier formed by the substantially ring-shapedsecond end piece is deformable in response to mechanically appliedpressure. In an aspect, the pressure includes fluid pressure applied byin flow of a second fluid composition from a second fluid reservoirportion, e.g., a syringe. In an aspect, the pressure includes airpressure.

In an aspect, the deformable barrier formed by the substantiallyring-shaped second end piece is deformable in response to appliedenergy. In an aspect, the deformable barrier formed by the substantiallyring-shaped second end piece is deformable in response to electrical,thermal, optical, acoustic, magnetic, or electromagnetic energy. In anaspect, the substantially ring-shaped second end piece is formed from adeformable material responsive to at least one of electrical, thermal,optical, acoustic, magnetic, or electromagnetic energy.

Returning to FIG. 14, the penetrating portion of penetrating device 1400includes penetrating edge 1412. In an aspect, the penetrating edge 1412includes a sharp piercing edge. In an aspect, the penetrating edge 1412includes a sharp bevelled edge. In an aspect, the penetrating edge 1412includes at least one sharp edge able to pierce a material. In anaspect, the penetrating edge 1412 includes at least one sharp edge ableto pierce metal, wood, concrete, plastic, polymer, fiberglass, resin,acrylic, latex, rubber, paper, or fabric. In an aspect, the penetratingedge 1412 includes at least one sharp edge able to pierce plantmaterial. In an aspect, the penetrating edge 1412 includes at least onesharp edge able to pierce a body tissue of an animal. In an aspect, thepenetrating edge 1412 includes at least one sharp edge able to pierceskin, endothelium, muscle, adipose, bone, cartilage, eye tissue, neuraltissue, or internal organ tissue.

Penetrating device 1400 includes fluid reservoir portion 1454 forholding a fluid composition, the fluid reservoir portion 1454 defined bythe first hollow cylinder 1430, the second hollow cylinder 1436, thesubstantially ring-shaped first end piece 1442, and the substantiallyring-shaped second end piece 1448, the fluid reservoir portion 1454 influid communication with the plurality of pores 1414. In an aspect, thefluid composition of the fluid reservoir portion 1454 includes at leastone lubricant. For example, the fluid reservoir portion can includeglycerol. In an aspect, the fluid composition of the fluid reservoirportion 1454 includes at least one of an anesthetic or an analgesic. Forexample, the fluid reservoir portion can include lidocaine. In anaspect, the fluid composition of the fluid reservoir portion 1454includes at least one antiseptic. For example, the fluid reservoirportion can include iodine. In an aspect, the fluid composition of thefluid reservoir portion 1454 includes at least one antimicrobial agent.For example, the fluid reservoir portion can include a topicalantibiotic. In an aspect, the fluid composition of the fluid reservoirportion 1454 includes at least one anticoagulant. For example, the fluidreservoir portion can include heparin. In an aspect, the fluidcomposition of the fluid reservoir portion 1454 includes at least oneantihemorrhagic. For example, the fluid reservoir portion can include astyptic agent. In an aspect, the fluid composition of the fluidreservoir portion 1454 includes at least one treatment agent. Forexample, the fluid reservoir portion can include a vaccine adjuvant. Inan aspect, the fluid composition of the fluid reservoir portion 1454includes at least one sealant. For example, the fluid reservoir portioncan include a cyanoacrylate. Additional non-limiting examples ofanesthetics, analgesics, antiseptics, antimicrobial agents,anticoagulants, antihemorrhagic agents, treatment agents, lubricants,and sealants have been described above herein. In an aspect, the fluidcomposition is incorporated into the fluid reservoir portion 1454 at thetime of manufacture. In an aspect, the fluid composition is incorporatedinto the fluid reservoir portion 1454 at the time of use.

In an aspect, the second end of the lumen defined by the second hollowcylinder is in fluid communication with a second fluid reservoirportion. In an aspect, the second fluid reservoir portion includes asyringe, non-limiting examples of which have been described aboveherein. For example, the penetrating device can be connected to astandard syringe, e.g., a 3 milliliter syringe, through the connectorportion associate with the first hollow cylinder. In an aspect, thesecond reservoir portion is in fluid communication with the secondhollow cylinder through a flow conduit, e.g., rubber tubing. In anaspect, a piece of rubber tubing is attached to the connector portion ofthe first hollow cylinder of the penetrating device. In an aspect, thesecond fluid reservoir portion functions as an aspiration device. In anaspect, the second fluid reservoir portion functions as a biopsy device.

With reference to FIGS. 17A and 17B, shown are schematics of apenetrating system. FIG. 17A shows an external view of penetratingsystem 1700. Penetrating system 1700 includes penetrating device 1710and second fluid reservoir portion 1720. Penetrating device 1710includes penetrating portion 1730 and connector portion 1740.Penetrating portion 1730 includes penetrating edge 1732 and a pluralityof pores 1734. Second fluid reservoir portion 1720 includes adaptorportion 1722 and initiator 1724. FIG. 17B illustrates an example of anassembled penetrating system 1700 including the connector portion 1740of penetrating device 1710 disposed over the adaptor portion (1722 ofFIG. 17A) of second fluid reservoir portion 1720, the second fluidreservoir portion 1720 in fluid communication with the penetratingdevice 1710.

FIGS. 18A and 18B illustrate further aspects of penetrating system 1700.FIG. 18 shows a schematic of a longitudinal cross-section throughpenetrating system 1700. Penetrating device 1710 includes a first hollowcylinder 1800 having a first end 1802 and a second end 1804, the firsthollow cylinder 1800 including a plurality of pores 1734, the second end1804 of the first hollow cylinder 1800 having a connector portion 1740.Penetrating device 1710 includes a second hollow cylinder 1806 having afirst end 1808 and a second end 1810, the second hollow cylinder 1806disposed within the first hollow cylinder 1800 and substantially coaxialto the first hollow cylinder 1800. Penetrating device 1710 includes asubstantially ring-shaped first end piece 1812 having an outer edge 1814and an inner edge 1816, the outer edge 1814 of the substantiallyring-shaped first end piece 1812 secured to the first end 1802 of thefirst hollow cylinder 1800 and the inner edge 1816 of the substantiallyring-shaped first end piece 1812 secured to the first end 1808 of thesecond hollow cylinder 1806, wherein the first hollow cylinder 1800, thesecond hollow cylinder 1806, and the substantially ring-shaped first endpiece 1812 form a penetrating edge 1732. Penetrating device 1710includes a substantially ring-shaped second end piece 1818 having anouter edge 1820 and an inner edge 1822, the outer edge 1820 of thesubstantially ring-shaped second end piece 1818 adjacent to a portion ofthe first hollow cylinder 1800 proximal to the second end 1804 of thefirst hollow cylinder 1800 and the inner edge 1822 of the substantiallyring-shaped second end piece 1818 adjacent to a portion of the secondhollow cylinder 1806 proximal to the second end 1810 of the secondhollow cylinder 1806, the substantially ring-shaped second end piece1818 forming a deformable barrier. Penetrating device 1710 includes afirst fluid reservoir portion 1824 for holding a first fluidcomposition, the first fluid reservoir portion 1824 defined by the firsthollow cylinder 1800, the second hollow cylinder 1806, the substantiallyring-shaped first end piece 1812, and the substantially ring-shapedsecond end piece 1818, the first fluid reservoir portion 1824 in fluidcommunication with the plurality of pores 1734. Penetrating device 1710includes a lumen 1826 defined by the second hollow cylinder 1806, thelumen 1826 having a first end 1828 and a second end 1830, the first end1828 of the lumen 1826 in fluid communication with the penetrating edge1732. Penetrating system 1700 further includes second fluid reservoirportion 1720 including an initiator 1724, the second fluid reservoirportion 1720 attached to the penetrating device 1710 through theconnector portion 1740 of the first hollow cylinder 1800, the secondfluid reservoir portion 1720 in fluid communication with the second end1830 of the lumen 1826 defined by the second hollow cylinder 1806.

Penetrating system 1700 includes a penetrating device 1710 including afirst hollow cylinder 1800. In an aspect, the first hollow cylinder 1800is formed from stainless steel. In an aspect, the first hollow cylinder1800 is formed from at least one of metal, alloy, plastic, glass,polymer, or ceramic. In an aspect, first hollow cylinder 1800 is formedfrom a porous material. In an aspect, the first hollow cylinder 1800 isformed from at least one of sintered metal particulate, glassparticulate, or ceramic particulate. First hollow cylinder 1800 includesa plurality of pores 1734. In an aspect, each of the plurality of pores1734 is substantially perpendicular to a central axis of the firsthollow cylinder 1800. In an aspect, each of the plurality of pores 1734is machined into the first hollow cylinder 1800. In an aspect, theconnector portion 1740 of the second end 1804 of the first hollowcylinder 1800 includes a fitting sized for attachment to the secondfluid reservoir portion 1720. In an aspect, the connector portion 1740of the second end 1804 of the first hollow cylinder 1800 includes aslip-tip fitting. In an aspect, the connector portion 1740 of the secondend 1804 of the first hollow cylinder 1800 includes a lock fitting,e.g., a screw fitting or a Luer lock fitting.

The penetrating device 1710 of system 1700 includes a second hollowcylinder 1806. In an aspect, the second hollow cylinder 1806 is formedfrom stainless steel. In an aspect, the second hollow cylinder 1806 isformed from at least one of metal, alloy, plastic, glass, polymer, orceramic. The penetrating device 1710 of system 1700 includes asubstantially ring-shaped first end piece 1812. In an aspect, thesubstantially ring-shaped first end piece 1812 is formed from at leastone of stainless steel, metal, alloy, plastic, glass, polymer, orceramic. In an aspect, the second hollow cylinder 1806 and thesubstantially ring-shaped first end piece 1812 are substantiallynon-porous.

The penetrating device 1710 of system 1700 includes a substantiallyring-shaped second end piece 1818. The substantially ring-shaped secondend piece 1818 forms a deformable barrier. In an aspect, the deformablebarrier includes a moveable barrier. In an aspect, the deformablebarrier formed by the substantially ring-shaped second end piece isdeformable in response to pressure. In an aspect, the deformable barrierformed by the substantially ring-shaped second end piece is deformablein response to manually applied pressure. In an aspect, the deformablebarrier formed by the substantially ring-shaped second end piece isdeformable in response to mechanically applied pressure.

In an aspect, the outer edge 1820 of the substantially ring-shapedsecond end piece is secured to a portion of the first hollow cylinder1800 proximal to the second end 1804 of the first hollow cylinder 1800and the inner edge 1822 of the substantially ring-shaped second endpiece 1818 secured proximal to the second end 1810 of the second hollowcylinder 1806, the substantially ring-shaped second end piece 1818formed from a deformable material. For example, the outer edge of thesubstantially ring-shaped second end piece is glued, welded, adhered, orotherwise secured to the inner wall of the first hollow cylinder and theinner edge of the substantially ring-shaped second end piece is glued,welded, adhered, or otherwise secured to the outer wall of the secondhollow cylinder.

FIGS. 19A and 19B illustrate aspects of a penetrating system 1900including a substantially ring-shaped second end piece formed from adeformable material. FIG. 19A is a schematic of a longitudinal crosssection through penetrating system 1900. Penetrating system 1900includes penetrating device 1710 and second fluid reservoir portion1720. Penetrating device 1710 includes a first hollow cylinder 1800having a first end 1802 and a second end 1804, the first hollow cylinder1800 including a plurality of pores 1734, the second end 1804 of thefirst hollow cylinder 1800 having a connector portion 1740. Penetratingdevice 1710 includes a second hollow cylinder 1806 having a first end1808 and a second end 1810, the second hollow cylinder 1806 disposedwithin the first hollow cylinder 1800 and substantially coaxial to thefirst hollow cylinder 1800. Penetrating device 1710 includes asubstantially ring-shaped first end piece 1812 having an outer edge 1814and an inner edge 1816, the outer edge 1814 of the substantiallyring-shaped first end piece 1812 secured to the first end 1802 of thefirst hollow cylinder 1800 and the inner edge 1816 of the substantiallyring-shaped first end piece 1812 secured to the first end 1808 of thesecond hollow cylinder 1806, wherein the first hollow cylinder 1800, thesecond hollow cylinder 1806, and the substantially ring-shaped first endpiece 1812 form a penetrating edge 1732. Penetrating device 1710includes a substantially ring-shaped second end piece 1910 having anouter edge 1920 and an inner edge 1930, the outer edge 1920 of thesubstantially ring-shaped second end piece 1910 secured to a portion ofthe first hollow cylinder 1800 proximal to the second end 1804 of thefirst hollow cylinder 1800 and the inner edge 1930 of the substantiallyring-shaped second end piece 1910 secured proximal to the second end1810 of the second hollow cylinder 1806, the substantially ring-shapedsecond end piece 1910 forming a deformable barrier. Penetrating device1710 includes a first fluid reservoir portion 1824 for holding a firstfluid composition, the first fluid reservoir portion 1824 defined by thefirst hollow cylinder 1800, the second hollow cylinder 1806, thesubstantially ring-shaped first end piece 1812, and the substantiallyring-shaped second end piece 1818, the first fluid reservoir portion1824 in fluid communication with the plurality of pores 1734.Penetrating device 1710 includes a lumen 1826 defined by the secondhollow cylinder 1806, the lumen 1826 having a first end and a secondend, the first end of the lumen 1826 in fluid communication with thepenetrating edge 1732. Penetrating system 1700 further includes secondfluid reservoir portion 1720 including an initiator 1724, the secondfluid reservoir portion 1720 attached to the penetrating device 1710through the connector portion 1740 of the first hollow cylinder 1800,the second fluid reservoir portion 1720 in fluid communication with thesecond end of lumen 1826 defined by the second hollow cylinder 1806. Inan aspect, the second fluid reservoir portion 1720 is configured to holda second fluid composition. In an aspect, the second fluid reservoirportion is configured to hold a captured sample.

FIG. 19B shows a schematic of fluid flow through a longitudinalcross-section through penetrating system 1900 in the presence ofpressure 1940. In an aspect, pressure 1940 is shown causing deformationof the deformable material of the substantially ring-shaped second endpiece 1910. In an aspect, deformation of the deformable material of thesubstantially ring-shaped second end piece induces flow of the firstfluid composition from the first fluid reservoir portion out at leastone of the plurality of pores. Shown is flow of the first fluidcomposition (shown as stippling) from the first fluid reservoir portion1824 and out at least one of the plurality of pores 1734 in response todeformation of a deformable material of substantially ring-shaped secondend piece 1910. Also shown is outflow of the second fluid composition1950 from the penetrating edge 1732 of penetrating device 1710 inresponse to actuation of initiator 1724. For example, downward pressure1940 on initiator 1724, e.g., a plunger, forces the second fluidcomposition 1950 from second fluid reservoir portion 1720, through lumen1826 of penetrating device 1710, and out penetrating edge 1732. Inaddition, but not illustrated in FIG. 19B, is optional subsequent inflowof aspirated captured sample past penetrating edge 1732 of penetratingdevice 1710 in response to reverse actuation of initiator 1724.

In an aspect, the deformation of the deformable material of thesubstantially ring-shaped second end piece is reversible, e.g.,reversibly altering the shape of the substantially ring-shaped secondend piece. In an aspect, the deformation of the deformable material ofthe substantially ring-shaped second end piece is irreversible, e.g.,irreversibly altering the shape of the substantially ring-shaped secondend piece.

In an aspect, the substantially ring-shaped second end piece 1910 isformed from a thin barrier of deformable material. For example, thesubstantially ring-shaped second end piece can be formed from a thinbarrier of reversibly deformable material, e.g., an elastomer. Forexample, the substantially ring-shaped second end piece can be formedfrom a thin barrier of irreversibly deformable material, e.g., a thinbarrier of aluminum. In an aspect, the substantially ring-shaped secondend piece 1910 is formed from a deformable polymer. For example, thesubstantially ring-shaped second end piece can be formed from adeformable plastic or rubber. In an aspect, the substantiallyring-shaped second end piece 1910 is formed from deformable plastic. Forexample, the substantially ring-shaped second end piece can be formedfrom a thin piece of molded low density polyethylene. Non-limitingexamples of plastics include polyethylene terephthalate, polyethylene,polyvinyl chloride, polyvinylidene chloride, polypropylene, polystyrene,nylons, polycarbonate, or polyurethanes. In an aspect, the substantiallyring-shaped second end piece 1910 is formed from a deformable metal. Forexample, the substantially ring-shaped second end piece can be formedfrom a thin sheet of aluminum. In an aspect, the deformable metalincludes a ductile metal, e.g., copper, silver, or gold. In an aspect,the substantially ring-shaped second end piece is formed from a shapememory metal, e.g., nickel titanium alloy.

In an aspect, the substantially ring-shaped second end piece of apenetrating device is formed from a moveable rigid, low-frictionmaterial. FIGS. 20A and 20B illustrate aspects of a penetrating systemincluding a substantially ring-shaped second end piece formed from arigid, low-friction material. FIG. 20A is a schematic of a longitudinalcross section through penetrating system 2000. Penetrating system 2000includes penetrating device 1710 and second fluid reservoir portion1720. Penetrating device 1710 includes a first hollow cylinder 1800having a first end 1802 and a second end 1804, the first hollow cylinder1800 including a plurality of pores 1734, the second end 1804 of thefirst hollow cylinder 1800 having a connector portion 1740. Penetratingdevice 1710 includes a second hollow cylinder 1806 having a first end1808 and a second end 1810, the second hollow cylinder 1806 disposedwithin the first hollow cylinder 1800 and substantially coaxial to thefirst hollow cylinder 1800. Penetrating device 1710 includes asubstantially ring-shaped first end piece 1812 having an outer edge 1814and an inner edge 1816, the outer edge 1814 of the substantiallyring-shaped first end piece 1812 secured to the first end 1802 of thefirst hollow cylinder 1800 and the inner edge 1816 of the substantiallyring-shaped first end piece 1812 secured to the first end 1808 of thesecond hollow cylinder 1806, wherein the first hollow cylinder 1800, thesecond hollow cylinder 1806, and the substantially ring-shaped first endpiece 1812 form a penetrating edge 1732. Penetrating device 1710includes a substantially ring-shaped second end piece 2010 having anouter edge 2020 and an inner edge 2030, the outer edge 2020 of thesubstantially ring-shaped second end piece 2010 adjacent to a portion ofthe first hollow cylinder 1800 proximal to the second end 1804 of thefirst hollow cylinder 1800 and the inner edge 2030 of the substantiallyring-shaped second end piece 2010 adjacent to a portion of the secondhollow cylinder 1806 proximal to the second end 1810 of the secondhollow cylinder 1806, the substantially ring-shaped second end piece2010 forming a deformable barrier. In an aspect, substantiallyring-shaped second end piece 2010 is formed from a rigid, low-frictionmaterial. In an aspect, the rigid, low-friction material includessilicone. Penetrating device 1710 includes a first fluid reservoirportion 1824 for holding a first fluid composition, the first fluidreservoir portion 1824 defined by the first hollow cylinder 1800, thesecond hollow cylinder 1806, the substantially ring-shaped first endpiece 1812, and the substantially ring-shaped second end piece 2010, thefirst fluid reservoir portion 1824 in fluid communication with theplurality of pores 1734. Penetrating device 1710 includes a lumen 1826defined by the second hollow cylinder 1806, the lumen 1826 having afirst end and a second end, the first end of the lumen 1826 in fluidcommunication with the penetrating edge 1732. Penetrating system 1700further includes second fluid reservoir portion 1720 for holding asecond fluid composition, second fluid reservoir portion 1720 includingan initiator 1724, the second fluid reservoir portion 1720 attached tothe penetrating device 1710 through the connector portion 1740 of thefirst hollow cylinder 1800, the second fluid reservoir portion 1720 influid communication with the second end of lumen 1826 defined by thesecond hollow cylinder 1806.

FIG. 20B shows a schematic of fluid flow through a longitudinalcross-section through penetrating system 2000 in the presence ofpressure 2040. In an aspect, pressure 2040 is shown causing movement ofthe substantially ring-shaped second end piece 2010. In an aspect,movement of the substantially ring-shaped second end piece formed fromthe rigid, low-friction material into the first fluid reservoir portioninduces flow of the first fluid composition from the first fluidreservoir portion out at least one of the plurality of pores. Shown isflow of the first fluid composition (shown as stippling) from the firstfluid reservoir portion 1824 and out at least one of the plurality ofpores 1734 in response to movement of substantially ring-shaped secondend piece 2010. Also shown is outflow of a second fluid composition 2050from the penetrating edge 1732 of penetrating device 1710 in response toactuation of initiator 1724. For example, downward pressure 2040 oninitiator 1724, e.g., a plunger, forces the second fluid composition2050 from second fluid reservoir portion 1720, through the lumen ofpenetrating device 1710, and out penetrating edge 1732.

Returning to FIG. 17, the penetrating portion of penetrating system 1700includes penetrating edge 1732. In an aspect, the penetrating edge 1732includes a sharp piercing edge. In an aspect, penetrating edge 1732includes a sharp bevelled edge. In an aspect, penetrating edge 1732includes at least one sharp edge able to pierce a material. In anaspect, penetrating edge 1732 includes at least one sharp edge able topierce metal, wood, concrete, plastic, polymer, fiberglass, resin,acrylic, latex, rubber, paper, or fabric. In an aspect, penetrating edge1732 includes at least one sharp edge able to pierce plant tissue. In anaspect, penetrating edge 1732 includes at least one sharp edge able topierce a body tissue of an animal. In an aspect, penetrating edge 1512includes at least one sharp edge able to pierce skin, endothelium,muscle, adipose, bone, cartilage, eye tissue, neural tissue, or internalorgan tissue.

Penetrating device 1710 of penetrating system 1700 includes first fluidreservoir portion 1824 for holding a first fluid composition, the firstfluid reservoir portion 1824 defined by the first hollow cylinder 1800,the second hollow cylinder 1806, the substantially ring-shaped first endpiece 1812, and the substantially ring-shaped second end piece 1818, thefirst fluid reservoir portion 1824 in fluid communication with theplurality of pores 1734. In an aspect, the first fluid composition ofthe first fluid reservoir portion 1824 includes at least one lubricant.In an aspect, the first fluid composition of the first fluid reservoirportion 1824 includes at least one of an anesthetic or an analgesic. Inan aspect, the first fluid composition of the first fluid reservoirportion 1824 includes at least one antiseptic. In an aspect, the firstfluid composition of the first fluid reservoir portion 1824 includes atleast one antimicrobial agent. In an aspect, the first fluid compositionof the first fluid reservoir portion 1824 includes at least oneanticoagulant. In an aspect, the first fluid composition of the firstfluid reservoir portion 1824 includes at least one antihemorrhagicagent. In an aspect, the first fluid composition of the first fluidreservoir portion 1824 includes at least one treatment agent. In anaspect, the first fluid composition of the first fluid reservoir portion1824 includes at least one sealant. Non-limiting examples ofanesthetics, analgesics, antiseptics, antimicrobial agents,anticoagulants, antihemorrhagic agents, treatment agents, lubricants,and sealants have been described above herein. In an aspect, the firstfluid composition is incorporated into the first fluid reservoir portion1824 at the time of manufacture. In an aspect, the first fluidcomposition is incorporated into the first fluid reservoir portion 1824at the time of use.

Penetrating device 1710 of penetrating system 1700 includes second fluidreservoir portion 1720 including an initiator 1724, the second fluidreservoir portion 1720 attached to the penetrating device 1710 throughthe connector portion 1740 of the first hollow cylinder 1800, the secondfluid reservoir portion 1720 in fluid communication with the second endof lumen 1826 defined by the second hollow cylinder 1806. In an aspect,second fluid reservoir portion 1720 is configured to hold a capturedsample, e.g., a blood or tissue sample. In an aspect, second fluidreservoir portion 1720 is configured to hold a second fluid composition.In an aspect, the second fluid composition includes at least onevaccine. For example, the second fluid composition can include a versionof the annual flu vaccine. Non-limiting examples of vaccines have beendescribed above herein. In an aspect, the second fluid compositionincludes at least one therapeutic agent. In an aspect, the at least onetherapeutic agent includes at least one of an anti-inflammatory agent,an antimicrobial agent, a chemotherapy agent, or a diabetes treatmentagent. For example, the second fluid composition can includelong-lasting insulin. Non-limiting examples of other therapeutic agentshave been described above herein. In an aspect, the second fluidcomposition includes a dye, e.g., a diagnostic dye. In an aspect, thesecond fluid composition includes a wash solution, e.g., saline. In anaspect, the second fluid composition of the second fluid reservoirportion is configured for at least one of percutaneous administration,intravenous administration, subcutaneous administration, intraocularadministration, intraosseus administration, epidural administration,intraarticular administration, intraperitoneal administration, intraoraladministration, or intramuscular administration.

In an aspect, the second end of the lumen defined by the second hollowcylinder of the penetrating device is in fluid communication with asecond fluid reservoir portion of the penetrating system. In an aspect,the second fluid reservoir portion includes a syringe, non-limitingexamples of which have been described above herein. In an aspect, thesecond fluid reservoir portion includes an aspiration device. In anaspect, the second fluid reservoir portion includes a biopsy device. Inan aspect, the second fluid reservoir portion includes an evacuatedtube. In an aspect, the initiator 1724 includes a plunger, e.g., astandard plunger associated with a standard syringe. In an aspect, theinitiator 1724 includes a pump, e.g., an infusion pump and/or anaspiration pump, to which the penetrating system can be attached.

In an aspect, the second fluid reservoir portion is in fluidcommunication with the lumen defined by the second hollow cylinder ofthe penetrating device through a flow conduit. In an aspect, the flowconduit includes tubing, e.g., surgical tubing. For example, the secondfluid reservoir portion can be connected to the penetrating device ofthe penetrating system through a piece of surgical tubing attached tothe connector portion of the penetrating device. FIG. 21 illustratesaspects of a penetrating system including a second fluid reservoirportion attached to a penetrating device through a flow conduit.Penetrating system 2100 includes penetrating device 2110 and secondfluid reservoir portion 2120. Penetrating device 2110 includes connectorportion 2130, penetrating edge 2140, and a plurality of pores 2150.Penetrating device 2110 includes the internal aspects of a penetratingdevice such as described in FIG. 18 including a substantiallyring-shaped second end piece forming a deformable barrier, deformationor movement of which induces flow of a first fluid composition from afirst fluid reservoir portion of penetrating device 2110 and out atleast one of the plurality of pores 2150. Connector portion 2130 ofpenetrating device 2110 is attached to second fluid reservoir portion2120 through flow conduit 2160. In an aspect, flow conduit 2160 includessurgical tubing. In an aspect, second fluid reservoir portion 2120 caninclude a syringe attached to penetrating device 2110 through flowconduit 2160, the syringe including a plunger for initiating flow. In anaspect, second fluid reservoir portion 2120 can include an infusion bagattached to penetrating device 2110 through flow conduit 2160, gravityused for initiating flow.

The second fluid reservoir portion of a penetrating system includes aninitiator. In an aspect, the initiator includes a plunger. In an aspect,the initiator includes gravity. In an aspect, the initiator includes apump. In an aspect, the initiator is associated with an aspiratordevice. In an aspect, the initiator is associated with a biopsy device.FIG. 22 illustrates aspects of a penetrating system including a secondfluid reservoir portion attached to a penetrating device through a pump.System 2200 includes penetrating device 2210 and second fluid reservoirportion 2220. Penetrating device 2210 includes connector portion 2230,penetrating edge 2240, and a plurality of pores 2250. Penetrating device2210 includes the internal aspects of a penetrating device such asdescribed in FIG. 18 including a substantially ring-shaped second endpiece forming a deformable barrier, deformation or movement of whichinduces flow of a first fluid composition from a first fluid reservoirportion of penetrating device 2210 and out at least one of the pluralityof pores 2250. Connector portion 2230 of penetrating device 2210 isattached to second fluid reservoir portion 2220 through flow conduit2260 and pump 2270. In an aspect, pump 2270 is a peristaltic pumpconfigured to pull the second fluid composition from second fluidreservoir portion 2220 into fluid conduit 2260, through pump 2270, andinto penetrating device 2210. In an aspect, the pump, e.g., an infusionpump, is positioned upstream of the second fluid reservoir portion andconfigured to push the second fluid composition from the second fluidreservoir portion, through the fluid conduit, and into the penetratingdevice. In an aspect, pump 2270 is an aspirating pump configured to pulla captured sample from an animal subject through penetrating device2210, the fluid conduit 2260, and into second fluid reservoir portion2220.

In an aspect, the second fluid reservoir portion is replaceable. Forexample, the second fluid reservoir portion can include a replaceableevacuated tube for blood collection, e.g., a BD Vacutainer® BloodCollection Tube from Becton, Dickinson and Company. For example, a firstevacuated tube attached to the penetrating device can be used to collecta first sample, removed upon filling, and a second evacuated tubeattached to the penetrating device to collect a second sample.

In an aspect, a penetrating system such as described in FIGS. 17 and 18includes a computing component operably coupled to the initiator, thecomputing component including a microprocessor. In an aspect, apenetrating system such as described in FIGS. 17 and 18 includes atleast one sensor. In an aspect, a penetrating system such as describedin FIGS. 17 and 18 includes at least one sensor operably coupled to thecomputing component, the computing component including circuitryconfigured to controllably actuate the initiator in response to inputfrom the at least one sensor. FIG. 23 illustrates aspects of apenetrating system including a computing component and at least onesensor. Penetrating system 2300 includes penetrating device 2310 andsecond fluid reservoir portion 2320. Penetrating device 2310 includespenetrating edge 2330, connector portion 2340, and a plurality of pores2350. Penetrating device 2310 includes all or part of the internalcomponents described in FIGS. 17 and 18 including a deformable and/ormoveable substantially ring-shaped second end piece. Second fluidreservoir portion 2320 includes initiator 2360. Penetrating system 2300further includes computing component 2370 operably coupled to initiator2360. Computing component 2370 includes a microprocessor and circuitryconfigured to controllably actuate initiator 2360. Penetrating system2300 further includes at least one sensor 2380. In an aspect, at leastone sensor 2380 includes at least one of an accelerometer, a clock, apressure sensor, a temperature sensor, a proximity sensor, or a chemicalsensor. At least one sensor 2380 is operably coupled to computingcomponent 2370 through communications link 2390. In an aspect, computingcomponent 2370 includes circuitry configured to controllably actuateinitiator 2360 in response to input from at least one sensor 2380. Forexample, the computing component can include circuitry configured toactuate initiator 2360 in response to input from a proximity indicatorindicating proximity to an injection target site.

FIG. 24 illustrates a penetrating system including a pump and acomputing component. Penetrating system 2400 includes penetrating device2410 and second fluid reservoir portion 2420. Penetrating device 2410includes penetrating edge 2430, connector portion 2440, and a pluralityof pores 2450. Penetrating device 2410 includes all or part of theinternal components described in FIGS. 17 and 18 including a deformableand/or moveable substantially ring-shaped second end piece, deformationor movement of which induces flow of a first fluid composition from afirst fluid reservoir portion out at least one of the plurality of pores2450. Connector portion 2440 of penetrating device 2410 is connected tosecond fluid reservoir portion 2420 through flow conduit 2460. Flowconduit 2460 is further connected to pump 2470. In an aspect, pump 2470is configured to initiate flow of a second fluid composition, e.g., avaccine or therapeutic agent, from the second fluid reservoir portion2420, through flow conduit 2460, and into a lumen of penetrating device2410. In an aspect, pump 2470 is configured to initiate flow of acaptured sample from an animal subject into penetrating device 2410,through flow conduit 2460, and into second fluid reservoir portion 2420.Pump 2470 is operably coupled through communications link 2490 tocomputing component 2480. In an aspect, computing component 2480 is adesk top computer. In an aspect, computing component 2480 isincorporated into or is a part of pump 2470.

With regard to FIGS. 25A and 25B, shown are aspects of a penetratingdevice. FIG. 25A is a schematic of the exterior of penetrating device2500. Penetrating device 2500 includes a penetrating portion 2502, afluid reservoir portion 2504, and a connector portion 2506. Penetratingportion 2502 further includes a penetrating edge 2508 and a plurality ofpores 2510. FIG. 25B shows a schematic of a cross-section throughpenetrating device 2500. Penetrating device 2500 includes first hollowcylinder 2512 having a first end 2514 and a second end 2516, firsthollow cylinder 2512 including a plurality of pores 2510. Penetratingdevice 2500 further includes a second hollow cylinder 2518 having afirst end 2520 and a second end 2522, the second hollow cylinder 2518disposed within the first hollow cylinder 2512 and substantially coaxialto the first hollow cylinder 2512, the second end 2522 of the secondhollow cylinder 2518 having a connector portion 2506. Penetrating device2500 further includes a substantially ring-shaped end piece 2524 havingan outer edge 2526 and an inner edge 2528, the outer edge 2526 of thesubstantially ring-shaped end piece 2524 secured to the first end 2514of the first hollow cylinder 2512 and the inner edge 2528 ofsubstantially ring-shaped end piece 2524 secured to the first end 2520of second hollow cylinder 2518, wherein the first hollow cylinder 2512,the second hollow cylinder 2518, and the substantially ring-shaped endpiece 2524 form penetrating edge 2508. Penetrating device 2500 furtherincludes internal fluid conduit 2530 defined by a space between thefirst hollow cylinder 2512 and the substantially coaxial second hollowcylinder 2518, the internal fluid conduit 2530 in fluid communicationwith the plurality of pores 2510 along the length of first hollowcylinder 2512. Penetrating device 2500 further includes a fluidreservoir portion 2504 for holding a fluid composition, the fluidreservoir portion including a hollow structure with a first end 2532 anda second end 2534, the hollow structure disposed over, and substantiallycoaxial to a region of the second hollow cylinder 2518 proximal to thesecond end 2522 of second hollow cylinder 2518, the first end 2532 ofthe hollow structure secured to the second end 2516 of the first hollowcylinder 2512 and the second end 2534 of the hollow structure securedproximal to the second end 2522 of second hollow cylinder 2518, thehollow structure in fluid communication with internal fluid conduit2530. Penetrating device 2500 further includes a lumen 2536 defined bythe second hollow cylinder 2518, the lumen 2536 having a first end 2538and a second end 2540, the first end 2538 of lumen 2536 in fluidcommunication with the penetrating edge 2508.

Penetrating device 2500 includes first hollow cylinder 2512. In anaspect, first hollow cylinder 2512 is formed from stainless steel. In anaspect, first hollow cylinder 2512 is formed from at least one of metal,alloy, plastic, glass, polymer, or ceramic. In an aspect, first hollowcylinder 2512 is formed from a porous material. For example, the firsthollow cylinder can be formed from a porous ceramic material. In anaspect, first hollow cylinder 2512 is formed from at least one ofsintered metal particulate, glass particulate, or ceramic particulate.Non-limiting examples of materials and methods for forming a firsthollow cylinder have been described above herein. In an aspect, each ofthe plurality of pores 2510 is substantially perpendicular to a centralaxis of the first hollow cylinder 2512. In an aspect, the plurality ofpores 2510 along the length of first hollow cylinder 2512 is machinedinto the first hollow cylinder 2512. For example, the plurality of porescan be drilled into the first hollow cylinder. In an aspect, theplurality of pores 2510 along the length of the first hollow cylinder2512 is machined into the first hollow cylinder 2512 using at least oneof a drill, a laser, or a waterjet. Additional non-limiting aspects ofpores have been described above herein.

Penetrating device 2500 further includes second hollow cylinder 2518. Inan aspect, second hollow cylinder 2518 includes an extended portionconfigured to engage a tube, for example an evacuated tube for bloodcollection, such as a BD Vacutainer® Blood Collection Tube from Becton,Dickinson and Company. In an aspect, the second hollow cylinder 2518 isformed from stainless steel. In an aspect, second hollow cylinder 2518is formed from at least one of metal, alloy, plastic, glass, polymer, orceramic. Non-limiting examples of materials and methods for forming asecond hollow cylinder have been described above herein.

Second hollow cylinder 2518 has a connector portion 2506 at the secondend 2522 of second hollow cylinder 2518. In an aspect, connector portion2506 is formed from the same material as second hollow cylinder 2518 andrepresents an extension of second hollow cylinder 2518. In an aspect,connector portion 2506 is formed from a different material from secondhollow cylinder 2518, but is secured or attached to the second end 2522of second hollow cylinder 2518. In an aspect, connector portion 2506 isformed from at least one of metal, alloy, plastic, glass, polymer, orceramic. In an aspect, connector portion 2506 of the second end 2522 ofsecond hollow cylinder 2518 is configured to connect to a second fluidreservoir portion. In an aspect, connector portion 2506 of the secondend 2522 of second hollow cylinder 2518 is configured to connect to asyringe. In an aspect, connector portion 2506 of the second end 2522 ofsecond hollow cylinder 2518 is configured to connect to an aspirator. Inan aspect, connector portion 2506 of the second end 2522 of secondhollow cylinder 2518 is configured to connect to a biopsy device. In anaspect, connector portion 2506 of the second end 2522 of second hollowcylinder 2518 is configured to connect to a shield of an evaporated tubesystem. In an aspect, connector portion 2506 of the second end 2522 ofsecond hollow cylinder 2518 is configured to connect to a dispensingapparatus, e.g., a laboratory or industrial dispensing apparatus. In anaspect, the second fluid reservoir portion includes a reservoirconnected to connector portion 2506 of penetrating device 2500 through aflow conduit, e.g., tubing or needle extension.

In an aspect, the connector portion 2506 of the second end 2522 of thesecond hollow cylinder 2518 includes a fitting sized for attachment to asyringe, the syringe including a second fluid reservoir portion. In anaspect, connector portion 2506 of the second end 2522 of second hollowcylinder 2518 includes a fitting sized for attachment to an aspirationdevice. In an aspect, connector portion 2506 of the second end 2522 ofsecond hollow cylinder 2518 includes a fitting sized for attachment to abiopsy device. In an aspect, connector portion 2506 of the second end2522 of second hollow cylinder 2518 includes a fitting sized forattachment to a shield of an evaporated tube system. In an aspect, theconnector portion 2506 of the second end 2522 of the second hollowcylinder 2518 includes a slip-tip fitting. In an aspect, the connectorportion 2506 of the second end 2522 of the second hollow cylinder 2518includes a lock fitting. In an aspect, the connector portion 2506 of thesecond end 2522 of the second hollow cylinder 2518 includes a Luer lockfitting.

Penetrating device 2500 includes substantially ring-shaped end piece2524. In an aspect, the substantially ring-shaped end piece 2524 isformed from at least one of stainless steel, metal, alloy, plastic,glass, polymer, or ceramic. In an aspect, the second hollow cylinder2518 and the substantially ring-shaped end piece 2524 are substantiallynon-porous. For example, the second hollow cylinder and thesubstantially ring-shaped end piece are formed either as a single pieceor as separate pieces from a material that is impermeable to thecontents, e.g., the fluid composition, of the fluid reservoir portionand the internal fluid conduit. In an aspect, substantially ring-shapedend piece 2524 is formed from the same material used to form secondhollow cylinder 2518. In an aspect, substantially ring-shaped end piece2524 is formed from a different material used to form second hollowcylinder 2518. In an aspect, substantially ring-shaped end piece 2524,first hollow cylinder 2512, and second hollow cylinder 2518 are formedfrom the same material, either as a single piece or as separate piecessecured to one another, each of the plurality of pores 2510 is machined,e.g., drilled, through the wall of first hollow cylinder 2512.

Penetrating device 2500 includes penetrating edge 2508 formed from firsthollow cylinder 2512, second hollow cylinder 2518, and substantiallyring-shaped end piece 2524. In an aspect, penetrating edge 2508 includesa sharp piercing edge. In an aspect, the penetrating edge 2508 includesa sharp beveled edge. In an aspect, the penetrating edge 2508 includesat least one sharp edge able to pierce a material. In an aspect, thepenetrating edge 2508 includes at least one sharp edge able to piercemetal, wood, concrete, plastic, polymer, fiberglass, resin, acrylic,latex, rubber, paper, or fabric. In an aspect, the penetrating edge 2508includes at least one sharp edge able to pierce plant material. In anaspect, the penetrating edge 2508 includes at least one sharp edge ableto pierce a body tissue of an animal. In an aspect, the penetrating edge2508 includes at least one sharp edge able to pierce skin, endothelium,muscle, adipose, bone, cartilage, eye tissue, neural tissue, or internalorgan tissue.

Penetrating device 2500 includes fluid reservoir portion 2504 includinga hollow structure attached at a first end 2532 to the second end 2516of first hollow cylinder 2512 and at a second end 2534 to a regionproximal to the second end 2522 of second hollow cylinder 2518. In anaspect, the hollow structure of the fluid reservoir portion 2504 isformed at least in part from a deformable material. In an aspect, thehollow structure of fluid reservoir portion 2504 is formed at least inpart from a material capable of being deformed or of undergoing a shapechange. In an aspect, the hollow structure of the fluid reservoirportion 2504 is formed at least in part from a deformable materialcapable of being deformed in response to pressure or stress. Forexample, the hollow structure of the first fluid reservoir portion canbe formed from a material capable of being deformed by manualapplication of pressure, e.g., squeezing, with two or more fingers. Inan aspect, deformation of the deformable material induces flow of thefluid composition from the fluid reservoir portion 2504, through theinternal fluid conduit 2530, and out at least one of the plurality ofpores 2510.

In an aspect, the deformable material is a material capable of elasticdeformation in which the deformation of the material is reversible. Forexample, the deformable material can include an elastomer or shapememory metals. In an aspect, the deformable material is a materialcapable of plastic deformation in which the deformation of the materialis irreversible. For example, the deformable material can includethermoplastics. In an aspect, the deformable material of the hollowstructure includes at least one deformable polymer. For example, thedeformable polymer can include a deformable plastic. For example, thedeformable polymer can include a deformable rubber.

In an aspect, the deformable material of the hollow structure includesdeformable plastic. For example, the deformable material of the hollowstructure can include a thin piece of molded low density polyethylene.Non-limiting examples of plastics include polyethylene terephthalate,polyethylene, polyvinyl chloride, polyvinylidene chloride,polypropylene, polystyrene, nylons, polycarbonate, or polyurethanes.

In an aspect, the deformable material of the hollow structure includesdeformable rubber. In an aspect, the deformable rubber includes naturalrubber. For example, the deformable rubber can include natural latexrubber and/or vulcanized natural rubber. In an aspect, the deformablerubber includes synthetic rubber. For example, the deformable rubber caninclude styrene-butadiene rubber.

In an aspect, the deformable material of the hollow structure includesdeformable metal. For example, the deformable material of the hollowstructure can include at least in part a thin sheet of aluminum. In anaspect, the deformable metal includes a ductile metal, e.g., copper,silver, or gold. In an aspect, the deformable metal includes a shapememory metal. For example, the deformable metal can include an alloy,e.g., nickel titanium.

In an aspect, the deformable material of the hollow structure includes athin wall of deformable material. For example, the deformable materialof the hollow structure includes a thin wall of at least one ofdeformable polymer, plastic, rubber, or metal. In an aspect, thedeformable material of the hollow structure is deformable in response toapplied pressure. For example, the deformable material of the hollowstructure can be configured to be squeezable. In an aspect, thedeformable material of the hollow structure is deformable in response tomanually applied pressure. For example, the deformable material of thehollow structure can be configured to deform in response to manuallysqueezing the deformable material with two of more fingers. In anaspect, the deformable material of the hollow structure is deformable inresponse to mechanically applied pressure. For example, the deformablematerial of the hollow structure can be configured to deform in responseto mechanically squeezing the deformable material with a vice, clamp,pincher, or other device configured to apply pressure to the deformablematerial.

In an aspect, the deformable material of the hollow structure isdeformable in response to applied energy. In an aspect, the deformablematerial of the hollow structure is deformable in response to electricalenergy, thermal energy, optical energy, acoustic energy, magneticenergy, or electromagnetic energy. In an aspect, the deformable materialof the hollow structure includes electro-active polymer, electro-activemetal, magnetically responsive material, thermo-responsive material,photo-responsive material, or acoustically responsive material. Forexample, the hollow structure can be formed from a photo-responsivematerial that deforms in response to a specific wavelength of light. Forexample, the hollow structure can be formed from a thermal-responsivematerial that swells and/or contracts in response to fluctuations intemperature.

Penetrating device 2500 includes fluid reservoir portion 2504 forholding a fluid composition. In an aspect, the fluid composition offluid reservoir portion 2504 includes at least one lubricant. In anaspect, the fluid composition of fluid reservoir portion 2504 includesat least one anesthetic. In an aspect, the fluid composition of fluidreservoir portion 2504 includes at least one antimicrobial agent. In anaspect, the fluid composition of fluid reservoir portion 2504 includesat least one analgesic. In an aspect, the fluid composition of fluidreservoir portion 2504 includes at least one treatment agent. In anaspect, the fluid composition of fluid reservoir portion 2504 includesat least one sealant. In an aspect, the fluid composition of fluidreservoir portion 2504 includes at least one anticoagulant. In anaspect, the fluid composition of fluid reservoir portion 2504 includesat least one antihemorrhagic agent. Non-limiting examples ofanesthetics, lubricants, antimicrobial agents, analgesics, treatmentagents, sealants, anticoagulants, and antihemorrhagic agents have beendescribed above herein.

FIGS. 26A and 26B illustrate further aspects of penetrating device 2500.FIG. 26A shows a schematic of an external view of penetrating device2500. In this view, the deformable material, e.g., deformable plastic,of fluid reservoir portion 2504 is being deformed using appliedpressure, e.g., squeezing pressure applied with two or more fingers2600. As a result of the applied pressure and deformation of fluidreservoir portion 2504, the fluid composition 2620 stored in the fluidreservoir portion is forced out at least one of the plurality of pores2510. FIG. 26B shows a schematic of a longitudinal cross-section throughpenetrating device 2500. Also shown is applied pressure 2610 anddeformation of fluid reservoir portion 2504. In an aspect, deformationof the deformable material of the fluid reservoir portion 2504 inducesflow of the fluid composition (shown as stippling) from the fluidreservoir portion 2504, through the internal flow conduit 2530, and outat least one of the plurality of pores 2510.

Referring back to FIG. 25B, penetrating device 2500 includes lumen 2536defined by the second hollow cylinder 2518. In an aspect, the second end2540 of lumen 2536 defined by second hollow cylinder 2518 is in fluidcommunication with a second fluid reservoir portion. In an aspect, thesecond fluid reservoir portion includes a syringe body. For example, thelumen of the penetrating device allows for passage of a second fluidcomposition to flow from the second fluid reservoir portion, e.g., asyringe, through the penetrating device and into the pierced material,e.g., into the skin. For example, the lumen of the penetrating deviceallows for passage of a captured sample, e.g., a blood sample, to flowfrom an animal subject, through the penetrating device, and into thesecond fluid reservoir portion, e.g., a syringe. In an aspect, thesecond fluid reservoir portion includes a reservoir attached to thepenetrating device through a flow conduit, e.g., tubing. In an aspect,the second fluid reservoir portion is part of an aspirating device. Inan aspect, the second fluid reservoir portion is part of a biopsydevice. in an aspect, the second fluid reservoir portion is an evacuatedtube device.

With reference to FIGS. 27A and 27B, shown is a schematic of apenetrating system. FIG. 27A shows a schematic of the components ofpenetrating system 2700 including a penetrating device 2710 and a secondfluid reservoir portion 2720. Penetrating device 2710 of penetratingsystem 2700 includes penetrating portion 2730, first fluid reservoirportion 2740, and connector portion 2750. Penetrating portion 2730includes penetrating edge 2732 and a plurality of pores 2734.Penetrating system 2700 further includes a second fluid reservoirportion 2720. The second fluid reservoir portion 2720 includes adaptor2722 sized for interaction with connector portion 2750 of thepenetrating device 2710. The second fluid reservoir portion 2720 furtherincludes initiator 2724. The second fluid reservoir portion 2720 is influid communication with a lumen of the penetrating device 2710. FIG.27B shows a schematic of the components of penetrating system 2700 in anassembled state. Penetrating device 2710 is connected to the secondfluid reservoir portion 2720 through the connector portion 2710 ofpenetrating device 2710 and the adaptor portion of the second fluidreservoir portion 2720.

FIGS. 28A and 28B illustrate further aspects of penetrating system 2700.FIG. 28A shows a schematic of an external view of penetrating system2700. Penetrating system 2700 includes penetrating device 2710 includingpenetrating portion 2730 with penetrating edge 2732 and a plurality ofpores 2734, first fluid reservoir portion 2740, and connector portion2750, and second fluid reservoir portion 2710 including initiator 2724.FIG. 28B shows a schematic of a longitudinal cross-section throughpenetrating system 2700. Penetrating system 2700 includes penetratingdevice 2710 and second fluid reservoir portion 2720. Penetrating deviceincludes a first hollow cylinder 2800 having a first end 2802 and asecond end 2804, the first hollow cylinder 2800 including a plurality ofpores 2734; a second hollow cylinder 2806 having a first end 2808 and asecond end 2810, the second hollow cylinder 2806 disposed within thefirst hollow cylinder 2800 and substantially coaxial to the first hollowcylinder 2800, the second end 2810 of the second hollow cylinder 2806having a connector portion 2750; a substantially ring-shaped end piece2812 having an outer edge 2814 and an inner edge 2816, the outer edge2814 of the substantially ring-shaped end piece 2812 secured to thefirst end 2802 of the first hollow cylinder 2800 and the inner edge 2816of the substantially ring-shaped end piece secured to the first end 2808of the second hollow cylinder 2806, wherein the first hollow cylinder2800, the second hollow cylinder 2806, and the substantially ring-shapedend piece 2812 for a penetrating edge 2732; an internal fluid conduit2818 defined by a space between the first hollow cylinder 2800 and thesubstantially coaxial second hollow cylinder 2806, the internal fluidconduit 2818 in fluid communication with the plurality of pores 2734along the length of the first hollow cylinder 2800; a first fluidreservoir portion 2740 for holding a first fluid composition, the firstfluid reservoir portion 2740 including a hollow structure with a firstend 2820 and a second end 2822, the hollow structure disposed over, andsubstantially coaxial to a region of the second hollow cylinder 2806proximal to the second end 2810 of the second hollow cylinder 2806, thefirst end 2820 of the hollow structure secured to the second end 2804 ofthe first hollow cylinder 2800 and the second end 2822 of the hollowstructure secured proximal to the second end 2810 of the second hollowcylinder 2806, the hollow structure in fluid communication with theinternal fluid conduit 2818; and a lumen 2824 defined by the secondhollow cylinder 2806, the lumen 2824 having a first end 2826 and asecond end 2828, the first end 2826 of the lumen 2824 in fluidcommunication with the penetrating edge 2732. Penetrating system 2700further includes a second fluid reservoir portion 2720 including aninitiator 2724, the second fluid reservoir portion 2720 attached to theconnector portion 2750 of the penetrating device 2710, the second fluidreservoir portion 2720 in fluid communication with the second end 2828of the lumen 2824 defined by the second hollow cylinder 2806.

Penetrating device 2710 of system 2700 includes first hollow cylinder2800. In an aspect, the first hollow cylinder 2800 is formed fromstainless steel. In an aspect, the first hollow cylinder 2800 is formedfrom at least one of metal, alloy, plastic, glass, polymer, or ceramic.In an aspect, the first hollow cylinder 2800 is formed from a porousmaterial. For example, the first hollow cylinder can be formed from aporous ceramic material. In an aspect, first hollow cylinder 2800 isformed from at least one of sintered metal particulate, glassparticulate, or ceramic particulate. Non-limiting aspects of materialsand methods for forming a first hollow cylinder have been describedabove herein.

First hollow cylinder 2800 includes a plurality of pores 2734. In anaspect, each of the plurality of pores 2734 is substantiallyperpendicular to a central axis of the first hollow cylinder 2800. In anaspect, each of the plurality of pores 2734 is machined into the firsthollow cylinder 2800. For example, the plurality of pores can be drilledinto the first hollow cylinder. Other non-limiting aspects of pores in afirst hollow cylinder have been described above herein.

Penetrating device 2710 of system 2700 further includes second hollowcylinder 2806. In an aspect, the second hollow cylinder 2806 is formedfrom stainless steel. In an aspect, second hollow cylinder 2806 isformed from at least one of metal, alloy, plastic, glass, polymer, orceramic.

Second hollow cylinder 2806 has a connector portion 2750 at the secondend 2810 of second hollow cylinder 2806. In an aspect the connectorportion 2750 is formed from the same material as second hollow cylinder2806 and represents an extension of second hollow cylinder 2806. In anaspect, connector portion 2750 is formed from a different material fromsecond hollow cylinder 2806, but is secured or attached to the secondend 2810 of second hollow cylinder 2806. In an aspect, connector portion2750 is formed from at least one of metal, alloy, plastic, glass,polymer, or ceramic. In an aspect, the connector portion 2750 of thesecond end 2810 of the second hollow cylinder 2806 includes a fittingsized for attachment to the second fluid reservoir portion 2720. In anaspect, the connector portion 2750 of the second end 2810 of the secondhollow cylinder 2806 includes a slip-tip fitting. In an aspect, theconnector portion 2750 of the second end 2810 of the second hollowcylinder 2806 includes a lock fitting. In an aspect, the connectorportion 2750 of the second end 2810 of the second hollow cylinder 2806includes a screw lock fitting or a Luer lock fitting.

Penetrating device 2710 of system 2700 includes a substantiallyring-shaped end piece 2812. In an aspect, the substantially ring-shapedend piece 2812 is formed from at least one of stainless steel, metal,alloy, plastic, glass, polymer, or ceramic. In an aspect, the secondhollow cylinder 2806 and the substantially ring-shaped end piece 2812are substantially non-porous. For example, the second hollow cylinderand the substantially ring-shaped end piece are formed either as asingle piece or as separate pieces from a material that is impermeableto the contents, e.g., the fluid composition, of the fluid reservoirportion and the internal fluid conduit. In an aspect, the substantiallyring-shaped end piece is formed from the same material used to form thesecond hollow cylinder. In an aspect, the substantially ring-shaped endpiece is formed from a different material used to form the second hollowcylinder. In an aspect, the substantially ring-shaped end piece, thefirst hollow cylinder, and the second hollow cylinder are formed fromthe same material, either as a single piece or as separate piecessecured to one another, wherein each of the plurality of pores ismachined, e.g., drilled, through the wall of the first hollow cylinder.

Penetrating device 2710 of system 2700 includes penetrating edge 2732formed from first hollow cylinder 2800, second hollow cylinder 2806, andsubstantially ring-shaped end piece 2812. In an aspect, the penetratingedge 2732 includes a sharp piercing edge. In an aspect, the penetratingedge 2732 includes a sharp beveled edge. In an aspect, the penetratingedge 2732 includes at least one sharp edge able to pierce a material. Inan aspect, the penetrating edge 2608 includes at least one sharp edgeable to pierce metal, wood, concrete, plastic, polymer, fiberglass,resin, acrylic, latex, rubber, paper, or fabric. In an aspect, thepenetrating edge 2732 includes at least one sharp edge able to pierceplant material. In an aspect, the penetrating edge 2732 includes atleast one sharp edge able to pierce a body tissue of an animal. In anaspect, the penetrating edge 2732 includes at least one sharp edge ableto pierce skin, endothelium, muscle, adipose, bone, cartilage, eyetissue, neural tissue, or internal organ tissue.

Penetrating device 2710 of system 2800 includes a first fluid reservoirportion 2740 for holding a first fluid composition, the first fluidreservoir portion 2740 including a hollow structure with a first end2820 and a second end 2822, the hollow structure disposed over, andsubstantially coaxial to a region of the second hollow cylinder 2806proximal to the second end 2810 of the second hollow cylinder 2806, thefirst end 2820 of the hollow structure secured to the second end 2804 ofthe first hollow cylinder 2800 and the second end 2822 of the hollowstructure secured proximal to the second end 2810 of the second hollowcylinder 2806, the hollow structure in fluid communication with theinternal fluid conduit 2818.

In an aspect, the hollow structure of the first fluid reservoir portion2740 is formed at least in part from a deformable material. In anaspect, the hollow structure of the first fluid reservoir portion 2740is formed at least in part from a material capable of being deformed orof undergoing a shape change. In an aspect, the hollow structure of thefirst fluid reservoir portion 2740 is formed at least in part from adeformable material capable of being deformed in response to pressure orstress. For example, the hollow structure of the first fluid reservoirportion can be formed from a material capable of being deformed bymanual application of pressure, e.g., squeezing, with two or morefingers. In an aspect, deformation of the deformable material inducesflow of the first fluid composition from first fluid reservoir portion2740, through the internal fluid conduit 2818, and out at least one ofthe plurality of pores 2734.

In an aspect, the deformable material is a material capable of elasticdeformation in which the deformation of the material is reversible. Inan aspect, the deformable material is a material capable of plasticdeformation in which the deformation of the material is irreversible. Inan aspect, the deformable material of the hollow structure includes adeformable polymer. For example, the deformable polymer can include adeformable plastic or deformable rubber. In an aspect, the deformablematerial of the hollow structure includes deformable plastic. Forexample, the deformable material of the hollow structure can include athin piece of molded low density polyethylene. Non-limiting examples ofplastics have been described above herein. In an aspect, the deformablematerial of the hollow structure includes deformable rubber. In anaspect, the deformable rubber includes natural rubber, e.g., naturallatex rubber, or synthetic rubber, e.g., styrene-butadiene rubber. In anaspect, the deformable material of the hollow structure includesdeformable metal. For example, the deformable material of the hollowstructure can include a thin portion of at least one of aluminum,copper, silver, gold, or a shape memory metal, e.g., nickel titanium.

In an aspect, the deformable material of the hollow structure includes athin wall of deformable material. For example, the deformable materialof the hollow structure includes a thin wall of at least one ofdeformable polymer, plastic, rubber, or metal. In an aspect, thedeformable material of the hollow structure is deformable in response toapplied pressure. For example, the deformable material of the hollowstructure can be configured to be squeezable. In an aspect, thedeformable material of the hollow structure is deformable in response tomanually applied pressure. For example, the deformable material of thehollow structure can be configured to deform in response to manuallysqueezing the deformable material with two or more fingers. In anaspect, the deformable material of the hollow structure is deformable inresponse to mechanically applied pressure. For example, the deformablematerial of the hollow structure can be configured to deform in responseto mechanically squeezing the deformable material with a vice, clamp,pincher, or other device configured to apply pressure to the deformablematerial.

In an aspect, the deformable material of the hollow structure isdeformable in response to applied energy. In an aspect, the deformablematerial of the hollow structure is deformable in response to electricalenergy, thermal energy, optical energy, acoustic energy, magneticenergy, or electromagnetic energy. In an aspect, the deformable materialincludes electro-active polymer, electro-active metal, magneticallyresponsive material, thermo-responsive material, photo-responsivematerial, or acoustically responsive material.

First fluid reservoir portion 2740 is configured to hold a first fluidcomposition. In an aspect, the first fluid composition of the firstfluid reservoir portion 2740 includes at least one lubricant. In anaspect, the first fluid composition of the first fluid reservoir portion2740 includes at least one anesthetic. In an aspect, the first fluidcomposition of the first fluid reservoir portion 2740 includes at leastone antimicrobial agent. In an aspect, the first fluid composition ofthe first fluid reservoir portion 2740 includes at least one analgesic.In an aspect, the first fluid composition of the first fluid reservoirportion 2740 includes at least one treatment agent. In an aspect, thefirst fluid composition of the first fluid reservoir portion 2740includes at least one sealant. In an aspect, the first fluid compositionof the first fluid reservoir portion 2740 includes at least oneanticoagulant. In an aspect, the first fluid composition of the firstfluid reservoir portion 2740 includes at least one antihemorrhagicagent. Non-limiting examples of anesthetics, lubricants, antimicrobialagents, analgesics, treatment agents, sealants, anticoagulants, andantihemorrhagic agents have been described above herein.

Penetrating system 2700 further includes a second fluid reservoirportion 2720. In an aspect, the second fluid reservoir portion 2720 isconfigured for holding a second fluid composition, e.g., a vaccine,therapeutic agent, dye, wash solution, or other agent. In an aspect, thesecond fluid reservoir portion 2720 is configured for holding a capturedsample, e.g., blood, tissue, marrow, aspirate, lavage, and the like. Inan aspect, the second fluid reservoir portion 2720 includes a syringe.For example, the lumen of the penetrating device allows for passage ofthe second fluid composition to flow from the second fluid reservoirportion, e.g., a syringe, through the penetrating device and into thepierced material, e.g., into the skin. For example, the lumen of thepenetrating device allows for passage of a captured sample to flow froman animal subject, through the penetrating device, and into the secondfluid reservoir portion, e.g., the body of a syringe. For example, thesecond fluid reservoir portion can include a standard syringe, e.g., a 1ml plastic syringe, attached to the connector portion of the penetratingdevice through a fitting, e.g., a slip-tip fitting or a Luer lockfitting. Non-limiting aspects of syringes have been described aboveherein. In an aspect, the second fluid reservoir portion 2720 includesan evacuated tube device. In an aspect, the second fluid reservoirportion 2720 includes an aspirator device. In an aspect, the secondfluid reservoir portion 2720 includes a biopsy device. In an aspect, thesecond fluid reservoir portion 2720 includes a reservoir attached to thepenetrating device through a flow conduit, e.g., tubing. For example,the second fluid reservoir portion can include an infusion bag forholding the second fluid composition, the infusion bag attached throughsurgical tubing to the penetrating device.

Second fluid reservoir portion 2720 includes an initiator 2724. In anaspect, initiator 2724 is configured to induce flow into or out of thesecond fluid reservoir portion 2720. In an aspect, initiator 2724 isconfigured to induce flow of a second fluid composition from the secondfluid reservoir portion 2720 through the lumen 2824 of the attachedpenetrating device 2710. In an aspect, initiator 2724 is configured toinduce flow of a captured sample from an animal subject, through thelumen 2824 of the attached penetrating device 2710, and into the secondfluid reservoir portion 2720. In an aspect, the initiator 2724 includesa plunger. For example, the initiator can include a plunger associatedwith a syringe. For example, the second fluid reservoir portion caninclude a standard syringe with an associated plunger. In an aspect, theinitiator 2724 includes a pump. For example, the initiator can includean infusion pump into which the penetrating system is inserted, theinfusion pump pushing on a plunger portion of the second fluid reservoirportion. For example, the initiator can include a peristaltic pumphaving tubing that connects a second fluid reservoir portion to thepenetrating device of the system. For example, the initiator can includean aspirating pump for pulling a capture sample out of an animal subjectand into the penetrating device. In an aspect, the initiator includes avalve. In an aspect, the initiator includes gravity. For example, flowfrom an infusion bag can be initiated by opening a valve and allowinggravity to flow the second fluid composition from the infusion bag. Inan aspect, the initiator includes a vacuum, e.g., a vacuum associatedwith an evacuated tube device.

The second fluid reservoir portion 2720 is configured to hold a secondfluid composition. In an aspect, the second fluid composition includesat least one vaccine. For example, the second fluid composition caninclude a version of the annual flu vaccine. Non-limiting examples ofvaccines have been described above herein. In an aspect, the secondfluid composition includes at least one therapeutic agent. In an aspect,the at least one therapeutic agent includes at least one of ananti-inflammatory agent, an antimicrobial agent, a chemotherapy agent,or a diabetes treatment agent. For example, the second fluid compositioncan include long-lasting insulin. Non-limiting examples of othertherapeutic agents have been described above herein. In an aspect, thesecond fluid composition includes at least one dye, e.g., a diagnosticdye. In an aspect, the second fluid composition includes a wash solutionfor an aspiration biopsy. In an aspect, the second fluid composition isformulated for at least one of percutaneous administration, intravenousadministration, subcutaneous administration, intraocular administration,intraosseus administration, epidural administration, intraarticularadministration, intraperitoneal administration, intraoraladministration, or intramuscular administration.

FIGS. 29A and 29B illustrate further aspects of penetrating system 2700.FIG. 29A shows a schematic of an external view of fluid flow frompenetrating system 2700. In this view, first fluid reservoir portion2740 is being deformed using applied pressure, e.g., squeezing pressureapplied with two or more fingers 2900. As a result of the appliedpressure and deformation of first fluid reservoir portion 2740, thefirst fluid composition 2910 stored in first fluid reservoir portion2740 is forced out at least one of the plurality of pores 2734. Alsoshown is outflow of the second fluid composition 2920 from thepenetrating edge 2732 of penetrating device 2710 in response toactuation of initiator 2724. For example, downward pressure on initiator2724, e.g., a plunger, forces the second fluid composition 2920 fromsecond fluid reservoir portion 2720, through the lumen of penetratingdevice 2710, and out penetrating edge 2732.

FIG. 29B shows a schematic of fluid flow through a longitudinalcross-section through penetrating system 2700. Shown is deformation of adeformable material of first fluid reservoir portion 2740 in response toapplied pressure 2930 resulting from squeezing first fluid reservoirportion 2740 with two or more fingers 2900 as shown in FIG. 29A. Alsoshown is flow of the first fluid composition (shown as stippling) fromthe first fluid reservoir portion 2740, through the internal flowconduit 2818, and out at least one of the plurality of pores 2734 inresponse to deformation of a deformable material of first fluidreservoir portion 2740. Also shown is outflow of the second fluidcomposition 2920 from the penetrating edge 2732 of penetrating device2710 in response to actuation of initiator 2724. For example, downwardpressure 2940 on initiator 2724, e.g., a plunger, forces the secondfluid composition 2920 from second fluid reservoir portion 2720, throughlumen 2824 of penetrating device 2710, and out penetrating edge 2732.During an aspiration procedure, upward pressure on initiator 2724 can beused to pull fluid, e.g., second fluid composition 2920 plus any cellsand/or tissue captured from a biopsy of an animal subject, back pastpenetrating edge 2732, through lumen 2824 of penetrating device 2710,and into the second fluid reservoir portion 2720.

In an aspect, the second fluid reservoir portion of a penetrating systemis in fluid communication with the second end of the lumen of thepenetrating device through a flow conduit. In an aspect, the flowconduit includes tubing, e.g., surgical tubing. FIGS. 30 and 31illustrate aspects of penetrating systems including a second fluidreservoir portion in fluid communication with the penetrating devicethrough a flow conduit. FIG. 30 is a schematic of an external view ofpenetrating system 3000. Penetrating system 3000 includes penetratingdevice 3010 and second fluid reservoir portion 3020. Penetrating device3010 includes penetrating portion 3030, first fluid reservoir portion3040, and connector portion 3050. Penetrating portion 3030 includespenetrating edge 3032 and a plurality of pores 3034. Penetrating portion3030 further includes all or part of the internal components describedin FIGS. 27 and 28 including a first hollow cylinder, a second hollowcylinder disposed with the first hollow cylinder, and a first fluidreservoir portion for holding a first fluid composition, the first fluidreservoir portion including a hollow structure with a first end and asecond end, the hollow structure disposed over, and substantiallycoaxial to a region of the second hollow cylinder proximal to the secondend of the second hollow cylinder, the first end of the hollow structuresecured to the second end of the first hollow cylinder and the secondend of the hollow structure secured proximal to the second end of thesecond hollow cylinder, the hollow structure in fluid communication withan internal fluid conduit and the plurality of pores 3034. Penetratingdevice 3010 is connected to second fluid reservoir portion 3020 throughconnector portion 3050 through flow conduit 3060, e.g., surgical tubing.

FIG. 31 is a schematic of an external view of penetrating system 3100.Penetrating system 3000 includes penetrating device 3010 and secondfluid reservoir portion 3020 as described in FIG. 30. Penetrating device3010 is connected to second fluid reservoir portion 3020 throughconnector portion 3050 through flow conduit 3060, e.g., surgical tubing.System 3100 further includes pump 3110 for initiating flow into or outof second fluid reservoir portion 3020 through flow conduit 3060,connector portion 3050, and through an internal lumen of penetratingdevice 3010.

In an aspect, a penetrating system, such as described in FIGS. 27-31,further includes a computing component operably coupled to theinitiator, the computing component including a microprocessor andcircuitry configured to controllably actuate the initiator. In anaspect, a penetrating system, such as described in FIGS. 27-31, furtherincludes at least one sensor. In an aspect, the at least one sensorincludes at least one of an accelerometer, a clock, a temperaturesensor, a pressure sensor, or a chemical sensor. In an aspect, thepenetrating system includes at least one sensor operably coupled to acomputing component, the computing component including circuitryconfigured to controllably actuate the initiator in response to inputfrom the at least one sensor.

FIG. 32 illustrates aspects of a penetrating system including acomputing component and at least one sensor. Penetrating system 3200includes penetrating device 3210 and second fluid reservoir portion3220. Penetrating device 3210 includes penetrating portion 3212, firstfluid reservoir portion 3214, and connector portion 3216. Penetratingportion 3212 includes penetrating edge 3218 and a plurality of pores3219. Second fluid reservoir portion 3220 includes initiator 3222.Penetrating system 3200 further includes computing component 3240. In anaspect, computing component 3240 includes a microprocessor and circuitryconfigured to controllably actuate initiator 3222. Penetrating system3200 further includes at least one sensor 3250 operably coupled tocomputing component 3240 through communications link 3260. In an aspect,the at least one sensor includes at least one of an accelerometer, aclock, a temperature sensor, a pressure sensor, a proximity sensor, or achemical sensor. Computing component 3240 includes circuitry configuredto controllably actuate initiator 3222 in response to input from atleast one sensor 3250.

FIG. 33 illustrates a penetrating system including a computing device.Penetrating system 3300 includes penetrating device 3310, second fluidreservoir portion 3320, and computing device 3330. Penetrating device3310 includes penetrating portion 3312, first fluid reservoir portion3314, and connector portion 3316. Penetrating portion 3312 includespenetrating edge 3318 for piercing a material 3340, e.g., a mammaliantissue, and a plurality of pores 3319. First fluid reservoir portion3314 includes a deformable material, e.g., deformable plastic, thatdeforms in response to applied pressure, e.g., pressure applied bysqueezing with two or more fingers 3350. First fluid reservoir portion3314 holds a first fluid composition, e.g., an analgesic, and is influid communication with the plurality of pores 3319. Connector portion3316 is in fluid communication with penetrating edge 3318 through acentral lumen running longitudinally through penetrating device 3310.Connector portion 3316 is connected through a fluid conduit 3360, e.g.,surgical tubing, to pump 3370 and second fluid reservoir portion 3320.In an aspect, the second fluid reservoir portion 3320 holds a secondfluid composition, e.g., one or more therapeutic agents. In an aspect,the second fluid reservoir portion 3320 is configured to hold a capturesample, e.g., a blood, biological fluid, or tissue sample. Computingdevice 3330 is operably coupled to pump 3370 and includes circuitryconfigured to controllably actuate pump 3370 through a communicationslink 3380. In an aspect, the penetrating system is used by a healthcareprovider to administer a therapeutic agent to a subject. The healthcareprovider manually squeezes the deformable material of the first fluidreservoir portion to induce flow of an analgesic, e.g., lidocaine,through the plurality of pores of the penetrating device to coat thepenetrating portion prior to or as the penetrating edge is piercing thetissue of the subject. The computing device controls flow of thetherapeutic agent from the second fluid reservoir portion, through thefluid conduit and the penetrating device, and into the tissue of thesubject. In an aspect, the penetrating system is used by a healthcareprovider to perform an aspirating biopsy. The healthcare providermanually squeezes the deformable material of the first fluid reservoirportion to induce flow of a lubricant through the plurality of pores ofthe penetrating device to coat the penetrating portion prior to or asthe penetrating edge is piercing the tissue of the subject. Thecomputing device controls a pump, e.g., an aspirating pump, to aspiratea captured sample, e.g., an ascites sample, from the subject and intothe second fluid reservoir portion. In an aspect, the penetrating systemincludes at least one sensor (e.g., an accelerometer, a clock, atemperature sensor, a pressure sensor, a proximity sensor, or a chemicalsensor) operably coupled to the computing device, the computing deviceincluding circuitry configured to controllably actuate the pump inresponse to input from the at least one sensor.

The state of the art has progressed to the point where there is littledistinction left between hardware, software, and/or firmwareimplementations of aspects of systems; the use of hardware, software,and/or firmware is generally (but not always, in that in certaincontexts the choice between hardware and software can becomesignificant) a design choice representing cost vs. efficiency tradeoffs.There are various vehicles by which processes and/or systems and/orother technologies described herein can be effected (e.g., hardware,software, and/or firmware), and that the preferred vehicle will varywith the context in which the processes and/or systems and/or othertechnologies are deployed. For example, if an implementer determinesthat speed and accuracy are paramount, the implementer may opt for amainly hardware and/or firmware vehicle; alternatively, if flexibilityis paramount, the implementer may opt for a mainly softwareimplementation; or, yet again alternatively, the implementer may opt forsome combination of hardware, software, and/or firmware. Hence, thereare several possible vehicles by which the processes and/or devicesand/or other technologies described herein can be effected, none ofwhich is inherently superior to the other in that any vehicle to beutilized is a choice dependent upon the context in which the vehiclewill be deployed and the specific concerns (e.g., speed, flexibility, orpredictability) of the implementer, any of which may vary. Those skilledin the art will recognize that optical aspects of implementations willtypically employ optically-oriented hardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations can include software or other control structures.Electronic circuitry, for example, may have one or more paths ofelectrical current constructed and arranged to implement variousfunctions as described herein. In some implementations, one or moremedia can be configured to bear a device-detectable implementation whensuch media hold or transmit device detectable instructions operable toperform as described herein. In some variants, for example,implementations can include an update or modification of existingsoftware or firmware, or of gate arrays or programmable hardware, suchas by performing a reception of or a transmission of one or moreinstructions in relation to one or more operations described herein.Alternatively or additionally, in some variants, an implementation caninclude special-purpose hardware, software, firmware components, and/orgeneral-purpose components executing or otherwise invokingspecial-purpose components. Specifications or other implementations canbe transmitted by one or more instances of tangible transmission mediaas described herein, optionally by packet transmission or otherwise bypassing through distributed media at various times.

Alternatively or additionally, implementations may include executing aspecial-purpose instruction sequence or otherwise invoking circuitry forenabling, triggering, coordinating, requesting, or otherwise causing oneor more occurrences of any functional operations described above. Insome variants, operational or other logical descriptions herein may beexpressed directly as source code and compiled or otherwise invoked asan executable instruction sequence. In some contexts, for example, C++or other code sequences can be compiled directly or otherwiseimplemented in high-level descriptor languages (e.g., alogic-synthesizable language, a hardware description language, ahardware design simulation, and/or other such similar mode(s) ofexpression). Alternatively or additionally, some or all of the logicalexpression may be manifested as a Verilog-type hardware description orother circuitry model before physical implementation in hardware,especially for basic operations or timing-critical applications. Thoseskilled in the art will recognize how to obtain, configure, and optimizesuitable transmission or computational elements, material supplies,actuators, or other common structures in light of these teachings.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one embodiment,several portions of the subject matter described herein can beimplemented via Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Arrays (FPGAs), digital signal processors (DSPs), orother integrated formats. However, some aspects of the embodimentsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, the mechanisms ofthe subject matter described herein are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the subject matter described herein applies regardless ofthe particular type of signal bearing medium used to actually carry outthe distribution.

In a general sense, those skilled in the art will recognize that thevarious embodiments described herein can be implemented, individuallyand/or collectively, by various types of electro-mechanical systemshaving a wide range of electrical components such as hardware, software,firmware, and/or virtually any combination thereof; and a wide range ofcomponents that may impart mechanical force or motion such as rigidbodies, spring or torsional bodies, hydraulics, electro-magneticallyactuated devices, and/or virtually any combination thereof.Consequently, as used herein “electro-mechanical system” includes, butis not limited to, electrical circuitry operably coupled with atransducer (e.g., an actuator, a motor, a piezoelectric crystal, a MicroElectro Mechanical System (MEMS), etc.), electrical circuitry having atleast one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of memory(e.g., random access, flash, read only, etc.)), electrical circuitryforming a communications device (e.g., a modem, communications switch,optical-electrical equipment, etc.), and/or any non-electrical analogthereto, such as optical or other analogs. Those skilled in the art willalso appreciate that examples of electro-mechanical systems include butare not limited to a variety of consumer electronics systems, medicaldevices, as well as other systems such as motorized transport systems,factory automation systems, security systems, and/orcommunication/computing systems. Those skilled in the art will recognizethat electro-mechanical as used herein is not necessarily limited to asystem that has both electrical and mechanical actuation except ascontext may dictate otherwise.

In a general sense, the various aspects described herein can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, and/or any combination thereof and can beviewed as being composed of various types of “electrical circuitry.”Consequently, as used herein “electrical circuitry” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of memory (e.g., random access, flash, readonly, etc.)), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, optical-electricalequipment, etc.). The subject matter described herein can be implementedin an analog or digital fashion or some combination thereof.

Those skilled in the art will recognize that at least a portion of thesystems and/or processes described herein can be integrated into a dataprocessing system. A data processing system generally includes one ormore of a system unit housing, a video display device, memory such asvolatile or non-volatile memory, processors such as microprocessors ordigital signal processors, computational entities such as operatingsystems, drivers, graphical user interfaces, and applications programs,one or more interaction devices (e.g., a touch pad, a touch screen, anantenna, etc.), and/or control systems including feedback loops andcontrol motors. A data processing system can be implemented utilizingsuitable commercially available components, such as those typicallyfound in data computing/communication and/or networkcomputing/communication systems.

This application may make reference to one or more trademarks, e.g., aword, letter, symbol, or device adopted by one manufacturer or merchantand used to identify and/or distinguish his or her product from those ofothers. Trademark names used herein are set forth in such language thatmakes clear their identity, that distinguishes them from commondescriptive nouns, that have fixed and definite meanings, or, in many ifnot all cases, are accompanied by other specific identification usingterms not covered by trademark. In addition, trademark names used hereinhave meanings that are well-known and defined in the literature, or donot refer to products or compounds for which knowledge of one or moretrade secrets is required in order to divine their meaning. Alltrademarks referenced in this application are the property of theirrespective owners, and the appearance of one or more trademarks in thisapplication does not diminish or otherwise adversely affect the validityof the one or more trademarks. All trademarks, registered orunregistered, that appear in this application are assumed to include aproper trademark symbol, e.g., the circle R or bracketed capitalization(e.g., [trademark name]), even when such trademark symbol does notexplicitly appear next to the trademark. To the extent a trademark isused in a descriptive manner to refer to a product or process, thattrademark should be interpreted to represent the corresponding productor process as of the date of the filing of this patent application.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory). A sale of a system or method may likewise occur in aterritory even if components of the system or method are located and/orused outside the territory.

Further, implementation of at least part of a system for performing amethod in one territory does not preclude use of the system in anotherterritory.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “operably coupled to” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components can be referred to herein as“configured to,” “configured by,” “configurable to,” “operable/operativeto,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.Those skilled in the art will recognize that such terms (e.g.“configured to”) can generally encompass active-state components and/orinactive-state components and/or standby-state components, unlesscontext requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationscan be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

Various non-limiting embodiments are described herein as PropheticExamples.

Prophetic Example 1 Manufacture of an Injection System with a PorousOuter Hollow Cylinder, a Nonporous Inner Hollow Cylinder and TwoConcentric Plungers Controlled by Microcircuitry

An injection system is constructed with two concentric hollow cylindersforming a penetrating portion and two concentric plungers (e.g., seeFIGS. 1 and 2) and controlled by a microprocessor and microcircuitry. Apressure sensor on the device signals when skin or tissue is contactedand the microprocessor initiates deployment of the penetrating portion,and delivery of lubricants, analgesics/anesthetics and vaccines and/ortherapeutic agents from the concentric hollow cylinders. Upon completionof drug delivery, the penetrating portion is retracted by the device andinformation on the injection is transmitted to a central computer.

An injection device with two concentric hollow cylinders and twoconcentric plungers is constructed from stainless steel and plastics.The outer hollow cylinder contains pores to allow the outflow ofanalgesics and lubricants which reduce the pain associated withintramuscular injections. For example, the outer hollow cylinder may befabricated from stainless steel (SS) by pulling heated SS tubes throughcircular dies to obtain the desired diameter of the hollow cylinder, andthen pores may be introduced in the hollow cylinder by micromachiningPenetrating devices with lateral pores are described (see e.g., U.S.Pat. No. 6,517,521 issued to Ly on Feb. 11, 2003, which is incorporatedherein by reference). Processes and technologies to manufacture customsyringes and needles are available (see e.g., CregannaInfoSheet fromCreganna-Tactx Medical, Campbell, Calif.) For example, a 19 gauge (0.686mm inner diameter), 2.54 cm outer hollow cylinder may be manufacturedwith approximately 0.050 cm diameter pores spaced approximately 0.08 cmapart for the length of the outer hollow cylinder by micromachining. Aninner hollow cylinder, approximately 23 gauge (0.641 mm outer diameter),2.54 cm long is fabricated and inserted in the outer hollow cylinder.Both hollow cylinders are processed by laser cutting and grinding tocreate a sharp edge tip (see FIG. 1). Stainless steel circular endpieces and collars (or connectors) are produced by micromachining andmicro-welded to the ends of the inner and outer hollow cylinders (seeFIGS. 1 and 2). The barrel of the device including concentric plungersand the inner and outer reservoirs are fabricated by injection moldingfrom polypropylene. Materials and methods for syringe construction aredescribed (see e.g., U.S. Patent Appl. No. 2010/0179478 by Kobayashi etal. published on Jul. 15, 2010 and U.S. Appl. No. 2007/0083155 by Mullerpublished on Apr. 12, 2007, which are incorporated herein by reference).A touch sensor is attached to the distal end of the device to detectcontact of the device with the skin. For example, a Force SensingResister is available from Interlink Electronics, Inc., Camarillo,Calif. which signals the microprocessor when the injection devicecontacts the skin surface. The microprocessor initiates actuation of theouter plunger to drive lubricant and anesthetic through the pores of theouter hollow cylinder to the exterior. For example the lubricant may bepolydimethylsiloxane (available from Dow-Corning, Midland, Mich.) andorganosiloxanes (see e.g., U.S. Pat. No. 5,911,711 issued to Pelkey onJun. 15, 1999 which is incorporated herein by reference), and theanesthetic may be Lidocaine Hydrochloride Solution 4% (available fromMorton Grove Pharmaceuticals, Morton Grove, Ill.). The electronicallyactuated penetrating portion is deployed at a predetermined depth(approximately 3.75 cm to achieve intramuscular delivery in an averageadult male deltoid muscle) as lubricant and analgesic flow from thepores in the outer hollow cylinder. Electromechanical devices to insertsyringes are described (see e.g., U.S. Pat. No. 8,308,741 and U.S. Pat.No. 6,547,755 which are incorporated herein by reference). For example amicro linear actuator with a range of 50 mm and accuracy of 15 μm isavailable from Zaber Technologies Inc., Vancouver, B.C., Canada (seee.g., Micro Linear Actuator Spec Sheet available online athttp://www.zaber.com/products/product_detail.php?detail=T-NA08A25-SV2which is incorporated herein by reference). Electromechanical actuatorswith integrated controllers are also used to drive the outer and innerplungers. After the penetrating portion is inserted the inner plunger isactuated and medicament is delivered intramuscularly. Completion ofdelivery, as sensed by movement of the actuator leads to retraction ofthe penetrating portion and transmission of data from the injectionsystem to a central computer. The date, time, location, medicament,dosage, injection site (e.g., deltoid muscle on right arm) aretransmitted to a central computer and incorporated in the patientelectronic health record.

Prophetic Example 2 An Injection System with Concentric Hollow Cylindersand a Single Plunger to Deliver a Vaccine, Lubricants and Anesthetics atan Injection Site

An injection system is constructed with two concentric hollow cylindersforming a penetrating portion and a single plunger. The outer hollowcylinder is porous and served by a first fluid reservoir portion cappedby a deformable membrane and holding a first fluid composition, e.g.,lubricants and anesthetic, and the inner hollow cylinder is nonporousand served by a second fluid reservoir portion holding a second fluidcomposition, e.g., a vaccine or a therapeutic agent (e.g., see FIGS. 19Aand 19B). Fluid flow from both reservoirs is controlled by a plungerwhich applies force directly to the vaccine in the second fluidreservoir portion, and indirectly to the deformable membrane on thefirst fluid reservoir portion, thereby driving the lubricants andanesthetic from the first fluid reservoir portion and laterally out theporous outer hollow cylinder (see FIG. 22B). The device containssensors, actuators, microcircuitry and microprocessors to guide theinjection and to record and transmit data from the injection.

The injection system includes an outer hollow cylinder which is porousand designed for lateral delivery of lubricants and anesthetics, and aninner hollow cylinder which is coaxial and nonporous for delivery of asecond fluid composition, e.g., a vaccine or therapeutic agent. Theinjection device includes two reservoirs, a first fluid reservoirportion and a second fluid reservoir portion which serve the outer andinner hollow cylinder respectively. The outer hollow cylinder isconstructed of a polymer with pores present on the sides of the outerhollow cylinder (see FIGS. 18A and 18B). For example, a microporouspolymer of polypropylene may have pores approximately 5 microns indiameter which allow fluid flow (see e.g., U.S. Pat. No. 4,186,745issued to Lewis et al. on Feb. 5, 1980 which is incorporated herein byreference). In contrast, the inner hollow cylinder is constructed of anonporous polymer. Methods and materials to construct plastic needlesare described (see, e.g., Kim & Colton (2005) J. Med. Eng. Technol.29:181-186, which is incorporated herein by reference). A substantiallyring-shaped first end piece at the penetrating edge is formed fromnonporous polymer by injection molding and cast in place to seal theknife edge tip of the injection device, and a flexible substantiallyring-shaped second end piece is placed between the inner and outerhollow cylinders in the connector portion of the device to cap the firstfluid reservoir portion (see FIGS. 19A and 19B). For example asubstantially ring-shaped second end piece of a flexible polymer (e.g.,butadiene) may be attached to the inner and outer hollow cylinders withan adhesive or by fusing the end piece to the hollow cylinders with heator microwaves (see e.g., U.S. Patent Appl. No. 2010/0179478, Ibid.). Thefirst fluid reservoir portion may be filled with lubricant andanesthetic prior to attaching the upper end piece or a syringe may beused to fill the first fluid reservoir portion by injection through theflexible upper end piece. For example the lubricant may bepolydimethylsiloxane (available from Dow-Corning, Midland, Mich.) andorganosiloxanes (see e.g., U.S. Pat. No. 5,911,711 issued to Pelkey onJun. 15, 1999, which is incorporated herein by reference), and theanesthetic may be Lidocaine Hydrochloride Solution 4% (available fromMorton Grove Pharmaceuticals, Morton Grove, Ill.). The uppermost end ofthe outer hollow cylinder (i.e., the connector portion; see FIGS. 19Aand 19B) may be constructed of nonporous polymer and in the form of aLuer-lock fitting which connects to a syringe with a correspondingLuer-lock male fitting. The syringe barrel forms the second fluidreservoir portion which contains and delivers vaccines and/ortherapeutic agents from the sharp edge tip of the penetrating portionwhen force is applied to the syringe plunger. In addition, fluidpressure on the deformable membrane covering the first fluid reservoirportion drives lubricant and anesthetic from the first fluid reservoirportion through the lateral pores in the outer hollow cylinder. See,e.g., FIG. 19B.

The injection device includes microcircuitry, microprocessors andsensors to detect, record and report injections to a central computersystem. For example an accelerometer may detect the motion associatedwith inserting the penetrating portion in the deltoid muscle of apatient and a pressure sensor may detect the application of force to asyringe plunger. The injection data are recorded by the microprocessorand transmitted to a central computer. For example the sensors mayrecord motion and pressure consistent with injection of a 0.5 mL dose ofvaccine intramuscularly. The date, time, patient identification, vaccinelot number, and other information, such as insurance company, healthcareworker, clinic location, are transmitted to a centralized computer (or acloud computer) and added to the patient's electronic health record.

Prophetic Example 3 An Injection System for Delivery of Medicaments withTwo Concentric Hollow Cylinders and Two Reservoirs which DeliversAnesthetics and Lubricants to Reduce the Pain Associated withIntramuscular Injections

An injection device is constructed with two concentric hollow cylindersforming a penetrating portion and two reservoirs which deliver to aninjection site a first fluid composition, e.g., lubricants andanesthetics, from a first fluid reservoir portion and a second fluidcomposition, e.g., a vaccine, from a second fluid reservoir portion. Afirst fluid reservoir portion is constructed as a flexible bulb which ismanually compressed to drive lubricants and anesthetic from the firstfluid reservoir portion through pores in an outer hollow cylinder. SeeFIGS. 29A and 29B. Insertion of the penetrating portion into muscletissue and initiation of flow of the vaccine from the second fluidreservoir portion is initiated by an automated system which iscontrolled by microcircuitry and microprocessors on the device.

The injection device with concentric hollow cylinders and two fluidreservoirs is constructed from stainless steel and polymers. The outerhollow cylinder contains pores to allow lateral outflow of analgesicsand lubricants which reduce the pain associated with intramuscularinjections. For example, the outer hollow cylinder may be fabricatedfrom stainless steel (SS) by pulling heated SS tubes through circulardies to obtain the desired diameter of the hollow cylinder, and thenpores may be introduced in the hollow cylinder by micromachiningPenetrating devices with lateral pores are described (see e.g., U.S.Pat. No. 6,517,521 issued to Ly on Feb. 11, 2003, which is incorporatedherein by reference), and processes and technologies to manufacturecustom syringes and needles are available (see e.g., CregannaInfoSheetfrom Creganna-Tactx Medical, Campbell, Calif.). For example a 19 gauge(0.686 mm inner diameter), 2.54 cm outer hollow cylinder may bemanufactured with approximately 0.050 cm diameter pores spacedapproximately 0.08 cm apart for the length of the outer hollow cylinderby micromachining. An inner hollow cylinder, approximately 23 gauge(0.641 mm outer diameter), 3.18 cm long is fabricated for insertionthrough the smaller spherical reservoir and the outer hollow cylinder(see FIG. 28B). A stainless steel ring-shaped end piece is produced bymicromachining and micro-welded to the distal, penetrating end of theinner and outer hollow cylinders and both hollow cylinders are processedby laser cutting and grinding to create a sharp beveled tip (see FIG.28B). The first fluid reservoir portion is fabricated using injectionmolding to create a spherical reservoir approximately 6 mm in diameterfrom flexible polypropylene. The spherical reservoir may have a pressuresensor to detect compression of the spherical reservoir. For example, aForce Sensing Resister is available from Interlink Electronics, Inc.,Camarillo, Calif. which signals the microprocessor when the sphericalreservoir is squeezed. The spherical reservoir is attached to the top ofthe outer hollow cylinder and the connector portion of the inner hollowcylinder (see, e.g., FIG. 28B) using adhesives and heat fusion to jointhe SS and polypropylene components (see e.g., U.S. Patent Appl. No.2010/0179478, Ibid.). The connector portion of the inner hollow cylindermay be constructed as a Luer-lock fitting which can accept a malesyringe fitting. The barrel of the syringe forms the second fluidreservoir portion and the syringe plunger drives flow of fluid from thesecond fluid reservoir portion through the penetrating end of the innerhollow cylinder for intramuscular delivery of the vaccine. The syringeplunger is actuated by an actuator that is controlled by themicroprocessor on the injection system. For example a micro linearactuator with a range of 50 mm and accuracy of 15 μm is available fromZaber Technologies Inc., Vancouver, B.C., Canada (see e.g., Micro LinearActuator Spec Sheet available online athttp://www.zaber.com/products/product_detail.php?detail=T-NA08A25-SV2which is incorporated herein by reference).

The injection system is assembled after entering health record data intoa central computer which communicates with the injection system device.The date, time, location, patient name, medication, route of delivery(e.g., intramuscular), lubricants, anesthetic and health care worker areentered and the appropriate injection system is indicated. For example,an intramuscular injection of an influenza vaccine in an adult maleselects an injection system with approximately 0.5 mL of vaccine in thelarge reservoir (i.e. the syringe barrel) and 0.25 mL of lubricant plusanesthetic in the small reservoir. The injection procedure follows:Holding the injection device near the injection site (e.g., arm) thefirst fluid reservoir portion is manually compressed forcing anestheticand lubricant out the plurality of pores along the length of the outerhollow cylinder (see, e.g., FIG. 29A), and the pressure sensor on thefirst fluid reservoir portion signals the processor to initiatedeployment of the penetrating portion and vaccine delivery. Theelectronically actuated penetrating portion is deployed at apredetermined depth (approximately 3.75 cm to achieve intramusculardelivery in an average adult male deltoid muscle) as lubricant andanalgesic flow from the pores in the outer hollow cylinder.Electromechanical devices to insert syringes are described (see e.g.,U.S. Pat. No. 8,308,741 and U.S. Pat. No. 6,547,755 which areincorporated herein by reference). Following deployment themicroprocessor initiates vaccine delivery by signaling the linearactuator to drive the syringe plunger. Following vaccine delivery thepenetrating portion is automatically retracted and the cumulativeinjection data is transmitted to a central computer.

All of the above U.S. patents, U.S. patent application publications,U.S. patent applications, foreign patents, foreign patent applicationsand non-patent publications referred to in this specification and/orlisted in any Application Data Sheet, are incorporated herein byreference, to the extent not inconsistent herewith.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. A penetrating device, comprising: a first hollowcylinder having a first end and a second end, the first hollow cylinderincluding a plurality of pores, the second end of the first hollowcylinder having a connector portion; a second hollow cylinder having afirst end and a second end, the second hollow cylinder disposed withinthe first hollow cylinder and substantially coaxial to the first hollowcylinder; a substantially ring-shaped first end piece having an outeredge and an inner edge, the outer edge of the substantially ring-shapedfirst end piece secured to the first end of the first hollow cylinderand the inner edge of the substantially ring-shaped first end piecesecured to the first end of the second hollow cylinder, wherein thefirst hollow cylinder, the second hollow cylinder, and the substantiallyring-shaped first end piece form a penetrating edge; a substantiallyring-shaped second end piece having an outer edge and an inner edge, theouter edge of the substantially ring-shaped second end piece adjacent toa portion of the first hollow cylinder proximal to the second end of thefirst hollow cylinder and the inner edge of the substantiallyring-shaped second end piece adjacent to a portion of the second hollowcylinder proximal to the second end of the second hollow cylinder, thesubstantially ring-shaped second end piece forming a deformable barrier;a fluid reservoir portion for holding a fluid composition, the fluidreservoir portion defined by the first hollow cylinder, the secondhollow cylinder, the substantially ring-shaped first end piece, and thesubstantially ring-shaped second end piece, the fluid reservoir portionin fluid communication with the plurality of pores; and a lumen definedby the second hollow cylinder, the lumen having a first end and a secondend, the first end of the lumen in fluid communication with thepenetrating edge. 2.-3. (canceled)
 4. The device of claim 1, wherein thefirst hollow cylinder is formed from a porous material.
 5. (canceled) 6.The device of claim 1, wherein each of the plurality of pores ismachined into the first hollow cylinder.
 7. The device of claim 1,wherein each of the plurality of pores is substantially perpendicular toa central axis of the first hollow cylinder.
 8. The device of claim 1,wherein the connector portion of the second end of the first hollowcylinder is configured to connect to a second fluid reservoir portion.9. (canceled)
 10. The device of claim 1, wherein the connector portionof the second end of the first hollow cylinder includes a fitting sizedfor attachment to a syringe, the syringe including a second fluidreservoir portion. 11.-12. (canceled)
 13. The device of claim 1, whereinthe connector portion of the second end of the first hollow cylinder isconfigured to connect to tubing attached to a second fluid reservoirportion. 14.-16. (canceled)
 17. The device of claim 1, wherein thesecond hollow cylinder and the substantially ring-shaped first end pieceare substantially non-porous.
 18. The device of claim 1, wherein thesubstantially ring-shaped second end piece is formed from a rigid,low-friction material.
 19. (canceled)
 20. The device of claim 18,wherein movement of the substantially ring-shaped second end pieceformed from the rigid, low-friction material in the fluid reservoirportion induces flow of the fluid composition from the fluid reservoirportion out at least one of the plurality of pores.
 21. The device ofclaim 1, wherein the outer edge of the substantially ring-shaped secondend piece is secured to a portion of the first hollow cylinder proximalto the second end of the first hollow cylinder, and the inner edge ofthe substantially ring-shaped second end piece secured proximal to thesecond end of the second hollow cylinder, the substantially ring-shapedsecond end piece formed from a deformable material. 22.-25. (canceled)26. The device of claim 21, wherein deformation of the deformablematerial of the substantially ring-shaped second end piece induces flowof the fluid composition from the fluid reservoir portion out at leastone of the plurality of pores.
 27. The device of claim 1, wherein thedeformable barrier formed by the substantially ring-shaped second endpiece is deformable in response to pressure. 28.-29. (canceled)
 30. Thedevice of claim 1, wherein the deformable barrier formed by thesubstantially ring-shaped second end piece is deformable in response toapplied energy. 31.-38. (canceled)
 39. The device of claim 1, whereinthe fluid composition of the fluid reservoir portion includes at leastone of an anesthetic or an analgesic.
 40. The device of claim 1, whereinthe fluid composition of the fluid reservoir portion includes at leastone of an antiseptic or an antimicrobial agent.
 41. (canceled)
 42. Thedevice of claim 1, wherein the fluid composition of the fluid reservoirportion includes at least one of an anticoagulant, an antihemorrhagic,or a treatment agent. 43.-44. (canceled)
 45. The device of claim 1,wherein the fluid composition of the fluid reservoir portion includes atleast one lubricant.
 46. The device of claim 1, wherein the fluidcomposition of the fluid reservoir portion includes at least onesealant. 47.-48. (canceled)
 49. The device of claim 1, wherein thesecond end of the lumen defined by the second hollow cylinder is influid communication with a second fluid reservoir portion.
 50. Apenetrating system, comprising: a penetrating device including a firsthollow cylinder having a first end and a second end, the first hollowcylinder including a plurality of pores, a second end of the firsthollow structure having a connector portion; a second hollow cylinderhaving a first end and a second end, the second hollow cylinder disposedwithin the first hollow cylinder and substantially coaxial to the firsthollow cylinder; a substantially ring-shaped first end piece having anouter edge and an inner edge, the outer edge of the substantiallyring-shaped first end piece secured to the first end of the first hollowcylinder and the inner edge of the substantially ring-shaped first endpiece secured to the first end of the second hollow cylinder, whereinthe first hollow cylinder, the second hollow cylinder, and thesubstantially ring-shaped first end piece form a penetrating edge; asubstantially ring-shaped second end piece having an outer edge and aninner edge, the outer edge of the substantially ring-shaped second endpiece adjacent to a portion of the first hollow cylinder proximal to thesecond end of the first hollow cylinder and the inner edge of thesubstantially ring-shaped second end piece adjacent to a portion of thesecond hollow cylinder proximal to the second end of the second hollowcylinder, the substantially ring-shaped second end piece forming adeformable barrier; a first fluid reservoir portion for holding a firstfluid composition, the first fluid reservoir portion defined by thefirst hollow cylinder, the second hollow cylinder, the substantiallyring-shaped first end piece, and the substantially ring-shaped secondend piece, the first fluid reservoir portion in fluid communication withthe plurality of pores; and a lumen defined by the second hollowcylinder, the lumen having a first end and a second end, the first endof the lumen in fluid communication with the penetrating edge; and asecond fluid reservoir portion including an initiator, the second fluidreservoir portion attached to the penetrating device through theconnector portion of the first hollow cylinder, the second fluidreservoir portion in fluid communication with the second end of thelumen defined by the second hollow cylinder. 51.-55. (canceled)
 56. Thesystem of claim 50, wherein each of the plurality of pores issubstantially perpendicular to a central axis of the first hollowcylinder.
 57. The system of claim 50, wherein the connector portion ofthe second end of the first hollow cylinder includes a fitting sized forattachment to the second fluid reservoir portion. 58.-62. (canceled) 63.The system of claim 50, wherein the second hollow cylinder and thesubstantially ring-shaped first end piece are substantially non-porous.64. The system of claim 50, wherein the substantially ring-shaped secondend piece is formed from a rigid, low-friction material.
 65. (canceled)66. The system of claim 64, wherein movement of the substantiallyring-shaped second end piece formed from the rigid, low-frictionmaterial in the first fluid reservoir portion induces flow of the firstfluid composition from the first fluid reservoir portion out at leastone of the plurality of pores.
 67. The system of claim 50, wherein theouter edge of the substantially ring-shaped second end piece is securedto a portion of the first hollow cylinder proximal to the second end ofthe first hollow cylinder and the inner edge of the substantiallyring-shaped second end piece secured proximal to the second end of thesecond hollow cylinder, the substantially ring-shaped second end pieceformed from a deformable material. 68.-71. (canceled)
 72. The system ofclaim 67, wherein deformation of the deformable material of thesubstantially ring-shaped second end piece induces flow of the firstfluid composition from the first fluid reservoir portion out at leastone of the plurality of pores.
 73. The system of claim 50, wherein thedeformable barrier formed by the substantially ring-shaped second endpiece is deformable in response to pressure.
 74. The system of claim 50,wherein the deformable barrier formed by the substantially ring-shapedsecond end piece is deformable in response to pressure from theinitiator of the second fluid reservoir portion. 75.-76. (canceled) 77.The system of claim 50, wherein the deformable barrier formed by thesubstantially ring-shaped second end piece is deformable in response toapplied energy. 78.-85. (canceled)
 86. The system of claim 50, whereinthe first fluid composition of the first fluid reservoir portionincludes at least one of an anesthetic, a lubricant, an antimicrobialagent, an analgesic, a treatment agent, a sealant, an anticoagulant, oran antihemorrhagic. 87.-95. (canceled)
 96. The system of claim 50,wherein the second fluid reservoir portion includes a syringe.
 97. Thesystem of claim 50, wherein the initiator includes a plunger.
 98. Thesystem of claim 50, wherein the initiator includes a pump.
 99. Thesystem of claim 50, wherein the initiator is configured to induce flowinto or out of the second fluid reservoir portion through the lumendefined by the second hollow cylinder of the penetrating device. 100.The system of claim 50, wherein the second fluid reservoir portion is influid communication with the lumen defined by the second hollow cylinderof the penetrating device through a flow conduit.
 101. (canceled) 102.The system of claim 50, wherein the second fluid reservoir portion isconfigured to hold a second fluid composition.
 103. The system of claim102, wherein the second fluid composition includes at least one of avaccine, a therapeutic agent, or a dye. 104.-107. (canceled)
 108. Thesystem of claim 50, wherein the second fluid reservoir portion isconfigured to hold a captured sample.
 109. The system of claim 50,further comprising a computing component operably coupled to theinitiator, the computing component including a microprocessor andcircuitry configured to controllably actuate the initiator. 110.(canceled)
 111. The system of claim 50, further comprising at least onesensor operably coupled to the computing component, the computingcomponent including circuitry configured to controllably actuate theinitiator in response to input from the at least one sensor.